Microsulis - News

Microsulis Medical receives FDA clearance for upgraded microwave ablation device

Wed, 19 Jun 2013 16:25:18 +0100

Microsulis Medical receives FDA clearance for upgraded microwave ablation device

DENMEAD, England – Tuesday 11 December, 2012: Microsulis Medical Ltd, the medical device company specialising in minimally invasive, microwave ablation technology for the coagulation of soft tissue, has received FDA clearance for its upgraded Accu2i pMTA applicator.

The initial version of the single, high-power, high-frequency 2.45GHz saline-cooled needle was cleared for use in the US as part of the Acculis MTA system in 2010. Following two years of global distribution, and in response to customer feedback and growing product demand, Microsulis has updated the device’s design and manufacturing process. Improvements include a refined optically clear moulded handle and improved connection cartridge.

Clinicians will continue to get the same results from Mark 2 of this market leading, minimally invasive product, while benefiting from improvements in the look and feel of the device. The changes also allow Microsulis to scale-up production output to satisfy its expanding customer base.

Stuart McIntyre, CEO of Microsulis Medical Ltd, said: “2.45GHz microwave ablation is becoming the new global standard for volume tissue coagulation, giving clinicians options for patients that were not possible with radiofrequency ablation technology.

“To keep up with demand and fuel the growth of this technology, it was necessary to introduce production and design solutions to allow large volume, scalable, high-quality manufacturing. Hence we have introduced a new improved design that has now received marketing clearance from the US Food and Drug Administration.

“The product continues to be available for global distribution and, with this clearance, we look forward to offering this new applicator to our many US based customers.”

Clinicians will notice the Accu2i pMTA applicator’s handle has undergone an ergonomic redesign, with ridged contact points and a more tactile feel. The optical grade clear applicator casing has been refined to allow the user to see the coolant flowing through the applicator. The coolant spike tubes have also been colour coded to provide a visual aid for ease of manufacture.

The Accu2i pMTA cartridge, that connects the applicator to the Local Control Station (LCS), has also been given an ergonomic makeover. Clinicians will notice the casing is both more pleasing to handle and robust in design, making it easier to use. Within the cartridge, parts have been revised to further improve the coolant flow through the system and simplify the build.

An animation of the new Accu2i pMTA applicator is available to view on YouTube.

ENDS

About Microsulis Medical Ltd

Microsulis Medical is a specialist medical device company with market leading solutions in microwave ablation. The company’s products deliver significant technological and clinical advances to physicians and patients in minimally invasive, soft tissue ablation.

The Acculis MTA system was CE Marked in February 2010 and 510(k) cleared by the U.S. Food and Drug Administration in August 2010. It is distributed globally, with the exception of the US, by AngioDynamics: www.AngioDynamics.com.

More information is available at www.microsulis.com.

Notes to editors

For more information or a hi-res image of the Accu2i pMTA applicator, please contact Claire Hall, Head of Marketing and Communications, on +44 (0)7766 365897 or at claire.hall@microsulis.com.

The FDA has cleared the Acculis MTA system for the coagulation of soft tissue. The Acculis MTA system has not been cleared or approved for any specific treatments or therapies of a specific disease or condition that may be mentioned in this press release.

Pancreatic Society of Great Britain and Ireland annual meeting

Wed, 19 Jun 2013 16:25:18 +0100

We are delighted to be supporting PSGBI's meeting at Loch Lomond. Find out more about this event on the organiser's website.

CIRSE Annual Congress

Wed, 19 Jun 2013 16:25:18 +0100

Our Acculis MTA system will be exhibited by our distribution partners AngioDynamics at CIRSE 2012. Visit them on Booth 31, Pavilion 2.

More information about the Acculis MTA system.

Contact our sales representatives.

Microsulis Medical to define microwave ablationâ��s role in surgery

Wed, 19 Jun 2013 16:25:18 +0100

Microsulis Medical to define microwave ablation’s role in surgery

DENMEAD, England – June 28, 2012: Microsulis Medical Ltd will be exploring microwave ablation’s (MWA) therapeutic role at a major surgical conference in Paris next week. The microwave ablation specialist’s Satellite Symposium is part of the industry programme at the 10th World Congress of the International Hepato-Pancreato-Biliary Association (IHPBA), which will be attended by 2,500 clinicians from across the globe.

Microsulis, an IHPBA gold sponsor, specialises in minimally invasive microwave technology for the coagulation, or destruction, of soft tissue. Clinicians have successfully used the company’s Acculis MTA system for interventional therapy and as an aid to resection, coagulating tissue in the liver, lung and kidney.

Leading Microsulis Medical’s IHPBA symposium will be some of the international surgical community’s established microwave users:

· Moderator - Professor John Primrose, University Hospital Southampton, UK

· Speaker - Dr David Iannitti, Carolinas Medical Center, US

· Speaker - Associate Professor Eduard Jonas, Karolinska University Hospital, Sweden

· Speaker - Professor Bernard Nordlinger, Hôpital Ambroise Paré, France.

Dr Iannitti will open the presentations by sharing his experience of how to use microwave ablation in surgery. Associate Professor Jonas will follow with a study of the application of microwave to achieve the best outcomes in different procedures. Professor Nordlinger will then investigate ablation’s role in conjunction with surgery and chemotherapy.

The presentations will be followed by a panel discussion to consider what trials are needed to define MWA’s role in the surgical community’s armamentarium.

The symposium ‘Is MWA now an established therapy? Where does it fit and how do we evidence it?’ takes place in Room Maillot, at the Palais des Congrès de Paris, between 12.30pm and 2pm, on Tuesday July 3. Find out more about the symposium and Microsulis Medical’s devices by visiting booth 29 in the exhibition hall.

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About Microsulis Medical

The Acculis MTA system is distributed globally, with the exception of the US, by AngioDynamics: www.AngioDynamics.com.

More information is available at www.microsulis.com.

Notes to editors

Microsulis Medical symposium to explore microwave ablation at European Conference on Interventional Oncology

Wed, 19 Jun 2013 16:25:18 +0100

DENMEAD, England – April 23, 2012: Microsulis Medical Ltd, the specialist in microwave ablation, will host a satellite symposium entitled ‘2.45GHz microwave ablation: top tips to improve outcomes in the liver and lung’ at the European Conference on Interventional Oncology (ECIO) in Florence, Italy, this week.

Moderating the symposium will be Prof Thomas Helmberger from Klinikum Bogenhausen, Germany. Speaking will be Prof Philippe Pereira from SLK-Kliniken Heilbronn, Germany, and Dr David Breen from University Hospitals of Southampton, UK.

Prof Pereira will discuss his experiences using microwave ablation compared to Radiofrequency Ablation (RFA) and share current results in the lung, while Dr Breen will share ten top tips for optimising outcomes in microwave ablation of the liver.

The symposium takes place in the Main Auditorium, Palazzo dei Congressi, between 5.30pm and 6pm, on Wednesday April 25. Find out more about the symposium and Microsulis’ devices at booth 5 in the exhibition hall.

Microsulis Medical's Acculis MTA system for the coagulation of soft tissue operates at 2.45GHz and is the most powerful device on the market when compared to Radio Frequency Ablation (RFA) devices and low power microwave systems.

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About Microsulis Medical

Notes to editors

Microsulis Medical establishes strategic relationship with AngioDynamics

Wed, 19 Jun 2013 16:25:18 +0100

DENMEAD, England - March 26, 2012: Microsulis Medical, the medical device company specialising in minimally invasive, microwave ablation technology for the coagulation of soft tissue has announced a multi-faceted strategic relationship with AngioDynamics (NASDAQ: ANGO). US company AngioDynamics is a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology.

The strategic relationship includes the following key elements:

• AngioDynamics has made a $5 million equity investment in Microsulis through the purchase of senior preferred stock, representing a 14.3% ownership position,

• AngioDynamics has been granted exclusive distribution rights to market and sell the Acculis microwave tissue ablation (MTA) system in all markets outside the United States from May 2012 through December 2013,

• AngioDynamics has been granted the exclusive option to purchase, at any time until September 22, 2013, substantially all of the global assets of Microsulis Medical Ltd., including the microwave ablation technology and its worldwide distribution rights.

“Over the past 15 years, Microsulis has developed what we believe to be the most technically advanced microwave ablation technology on the market today,” said Stuart McIntyre, Chief Executive Officer of Microsulis. "We are excited to have AngioDynamics, with its leading position in surgical oncology, as our strategic partner and very much look forward to working with them in bringing our products to patients across the globe.”

Joseph M. DeVivo, President and Chief Executive Officer of AngioDynamics, said: “This strategic relationship reflects the commitment to investing in the future growth of our Oncology/Surgery business, and illustrates our focus on leveraging our strong Oncology/Surgery sales team.

"We believe Microsulis’ technology is the most innovative microwave system on the market today. The addition of this breakthrough technology will solidify AngioDynamics as the clear market-leading innovator in the $250 million global tissue ablation market, with a full offering of thermal and non-thermal technologies that includes microwave, radiofrequency and the NanoKnife® System. We expect the agreement will have a modest revenue contribution in fiscal year 2013.”

Microsulis’ flagship product, the Accu2i pMTA applicator for percutaneous use, utilizes a single, high-power, high-frequency 2.45GHz saline-cooled needle that delivers significant advantages to clinicians and patients, including faster and larger soft tissue ablations. The device was CE Marked in February 2010 and 510(k) cleared by the U.S. Food and Drug Administration in August 2010.

Morgan Joseph TriArtisan LLC served as exclusive financial advisor to Microsulis Medical Ltd.

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About AngioDynamics

AngioDynamics, Inc. is a leading provider of innovative, minimally invasive medical devices used by professional healthcare providers for vascular access, surgery, peripheral vascular disease and oncology. AngioDynamics’ diverse product lines include market-leading ablation systems, vascular access products, angiographic products and accessories, angioplasty products, drainage products, thrombolytic products and venous products. More information is available at www.AngioDynamics.com.

About Microsulis Medical

European Lung Cancer Conference

Wed, 19 Jun 2013 16:25:18 +0100

We are pleased to be exhibiting at this event. Visit us on booth 1025. For more information see the organisers' website.

Microsulis scoops two prizes at business awards

Wed, 19 Jun 2013 16:25:18 +0100

DENMEAD, ENGLAND – February 13, 2012: Microsulis Medical Ltd has been named ‘Innovator of the Year’ at The News Business Excellence Awards in Portsmouth. The specialist medical device maker also claimed the runner up prize in the ‘Exporter of the Year’ category.

The award ceremony brought together some of the South of England’s top companies to celebrate excellence in industry. In particular, Microsulis Medical’s Acculis Microwave Tissue Ablation (MTA) system was recognised by the judges as a major innovation in the treatment cancer in a number of tissue types.

Stuart McIntyre, Chief Executive of Microsulis, said: “The Acculis MTA system has been in development for many years, and is now helping to improve quality of life and life expectancy for the seriously ill. The system uses microwave heat to treat unwanted tissue, such as tumours, and is the only technology of its kind being manufactured in the UK.”

The Acculis MTA system operates at 2.45GHz and is the most powerful device on the market when compared to Radio Frequency Ablation (RFA) devices and low power microwave systems. There are now more than 100 systems in hospitals and medical centres world-wide.

Mr McIntyre added: “We are delighted to have been recognised as a company bringing innovation to our region and industry.”

The awards ceremony, held at Portsmouth Guildhall on Friday February 10, was attended by more than 300 business leaders. Runners up in the Innovation category were Pure Hold and highly commended were Ilford Biomedia. More information about the winners and runners up is available on The News website.

Last month, the Acculis MTA system was recognised as a leading ablative tool in the Which Medical Device awards when it came runner up in the interventional radiology category.

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About Microsulis Medical

We are a specialist medical device company with market leading, game changing solutions in microwave ablation. Our products deliver significant technological and clinical advances to physicians and patients in minimally invasive, soft tissue ablation. The Accu2i pMTA applicator was CE-marked in February 2010, FDA 510(k) cleared in August 2010, approved for use in Australia and New Zealand in August 2010, and gained a Health Canada license in January 2011. We are a UK-based company, marketing our products on five continents. For more information about the Acculis MTA system visit: www.microsulis.com.

10th World Congress of the International Hepato-Pancreato-Biliary Association (IHPBA)

Wed, 19 Jun 2013 16:25:18 +0100

We are delighted to be Gold Sponsors of this congress meeting. As well as exhibiting our Acculis Microwave Tissue Ablation (MTA) system at booth 29, we will be holding a satellite symposium in Room Maillot, 12.30pm to 2pm, on Tuesday July 3.

Is MWA now an established therapy? Where does it fit and how do we evidence it?

Moderator - Professor John Primrose, University Hospital Southampton, UK

Dr David Iannitti, Carolinas Medical Center, US

Do we understand how to use MWA?

Associate Professor Eduard Jonas, Karolinska University Hospital, Sweden

Best ablation outcomes...percutaneous, laparoscopic or open?

Professor Bernard Nordlinger, Hopital Ambroise Pare, France

Is ablation a valid replacement for surgery or simply an adjunct to chemotherapy?

The presentations will be followed by an International Panel Discussion: 'What trials are needed to define MWA's role in our armamentarium?'

Find out more about this symposium by reading our press release.

Find out more about the congress on the organisers' website.

Digestive Disorders Federation Meeting (DDFM)

Wed, 19 Jun 2013 16:25:18 +0100

We are delighted to be exhibiting at this meeting. Find out more about the event at the organisers' website.

World Conference on Interventional Oncology (WCIO)

Wed, 19 Jun 2013 16:25:18 +0100

We are delighted to be exhibiting at this event. You can come and see us on booth 202-204.

For more information about this conference go to the organisers' website.

Global Embolization Symposium and Technologies (GEST)

Wed, 19 Jun 2013 16:25:18 +0100

We are delighted to be exhibiting at this event. Find out more on the organisers' website.

Society of Interventional Radiology 37th Annual Scientific Meeting

Wed, 19 Jun 2013 16:25:18 +0100

As part of the scientific programme we will be taking part in two hands-on workshops investigating new ablative technologies, both entitled Oncology V: Introduction to Tumor Ablation (Hands On). Delegates will be shown several ablative devices, including the Acculis MTA system, and discuss their applications in the liver, lung and kidney. There will also be case presentations sharing techniques, clincial scenarios and technical tips.

The workshops take place in Room 308 at the Moscone Centre between 1.30pm and 3.30pm on Monday, March 26, and 8am and 10am on Wednesday, March 28.

We will also be demonstrating our microwave ablation technology on booth 226 throughout the event.

Find out more about this event at the organisers' website.

Americas Hepato-Pancreato-Biliary Association Conference

Wed, 19 Jun 2013 16:25:18 +0100

We are delighted to be sponsors of this conference at the Eden Roc on Miami Beach. Join us for the golf tournament on Wednesday March 7 and visit us on booth 2-3 throughout the event.

Find out more about this event on the organisers' website.

Third European Conference on Interventional Radiology (ECIO)

Wed, 19 Jun 2013 16:25:18 +0100

We are delighted to be Platinum Sponsor of this prestigious event, during which we will be hosting a satellite symposium:

2.45Ghz microwave ablation: top tips to improve outcomes in the liver and lung

Join our clinical discussion session to debate specific user techniques for exploiting high power microwave ablation technology in clinical practice in liver and lung tissues.

Moderating the symposium will be Prof Thomas Helmberger from Klinikum Bogenhausen, Germany.

Speaker one: Prof Philippe L Pereira from SLK-Kliniken Heilbronn, Germany, 'Microwave at 2.45GHz in the lung, better than RFA: own experience and current results'

Speaker two: Dr David Breen from University Hospitals of Southampton, UK, 'Ten top tips for optimising outcomes in microwave ablation of the liver'

The symposium takes place in the Main Auditorium, between 17:30 and 18:00, on Wednesday April 25.

You can also see the high power 2.45GHz Acculis MTA system in action during the Image-guided tumour ablation workshops on Wednesday 25, Thursday 26 and Friday April 27 at the Palazzo dei Congressi. See the conference programme for more details. Alternatively, visit us on booth 5.

Find out more on the organisers' website.

Microsulis Medical agrees partnership with Gelisim Medikal for distribution of its microwave ablation system in Turkey

Wed, 19 Jun 2013 16:25:18 +0100

Microsulis Medical agrees partnership with Gelisim Medikal for distribution of its microwave ablation system in Turkey

DENMEAD, ENGLAND – December 13, 2011: Microsulis Medical Ltd has launched its groundbreaking Acculis Microwave Tissue Ablation (MTA) system in the Turkish oncology market after signing a distribution deal with Gelisim Medikal.

Microsulis Medical is a specialist in minimally invasive, microwave ablation technology for the coagulation of soft tissue and currently has more than 100 systems in hospitals world-wide. Clinicians have successfully used the system to coagulate diseased soft tissue in the lung, liver, kidney and bone.

Recent research* has shown cancer incidences are on the increase in Turkey, with lung cancer most prevalent. In order to introduce its products to the Turkish market, Microsulis Medical has chosen Gelisim Medikal as its distribution partner. The Istanbul-based company has more than 10 years experience in marketing medical devices for spinal surgery and has recently established an oncology team.

Stuart McIntyre, Chief Executive of Microsulis Medical, said: “There is a gap in the Turkish market for a device that offers minimally invasive, microwave ablation treatment. The unique design of our Acculis MTA system allows for shorter treatment times, precise control of microwave energy and larger coagulation areas using a single applicator. This provides a wider choice of treatment options to patients whose conditions might have previously been inoperable. We are pleased to be working with Gelisim Medikal to bring our innovative technology to this transcontinental marketplace.”

The Acculis MTA system operates at 2.45GHz and is the most powerful device on the market when compared to Radio Frequency Ablation (RFA) devices and low power microwave systems.

The premier product in the Acculis MTA range is the Accu2i pMTA applicator. It is a single high power, high frequency 2.45GHz, saline-cooled needle that is between three to 10 times faster than other devices. Doctors insert the needle through a puncture in the skin, also known as a percutaneous procedure, to reach internal organs or tissue. It is then activated and can coagulate tissue masses up to 5.6cm in size in just six minutes. This is between three and 10 times faster than other devices. For more information, go to: www.microsulis.com.

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About Microsulis Medical

Notes to editors

* ‘Cancer Trends and Incidence and Mortality Patterns in Turkey’, (2009), http://jjco.oxfordjournals.org/content/41/1/10.abstract.

Alpine Liver and Pancreatic Surgery Meeting (ALPS)

Wed, 19 Jun 2013 16:25:18 +0100

We are delighted to be sponsoring this meeting and look forward to attending.

For more information about the event see the organiser's website.

AHPBA Sponsored Consensus Conference on the Multidisciplinary Treatment of Colorectal Cancer Liver Metastases (CLM)

Wed, 19 Jun 2013 16:25:18 +0100

We are pleased to be attending this AHPBA sponsored meeting.

Find out more about this event on the organiser's website.

Microsulis Medicalâ��s ablation device used in first microwave assisted robotic liver resection

Wed, 19 Jun 2013 16:25:18 +0100

Microsulis Medical’s ablation device used in first microwave assisted robotic liver resection

DENMEAD, ENGLAND - Monday November 28, 2011: Microsulis Medical Ltd’s high powered, percutaneous microwave needle - the Accu2i pMTA applicator - has become the first ablation device of its kind documented to play a crucial role in a liver resection using the da Vinci Surgical System.

Microsulis is a medical device developer specialising in minimally invasive microwave technology for the coagulation, or destruction, of soft tissue. Clinicians have successfully used the company’s devices to coagulate tissue in the liver, lung, kidney and bone.

The recent hepatectomy involving the da Vinci Surgical System and Accu2i pMTA was carried out by Dr Adrian Legaspi, MD, at Mount Sinai Medical Center, Florida.

The patient, a 60-year-old female, presented with a liver lesion measuring 3.5cm. Dr Legaspi used the da Vinci’s state-of-the-art robotic technology to operate through tiny incisions in the patient’s abdomen. Using intra-operative ultrasound and direct visual guidance he located the target coagulation zones and used the da Vinci system to place the Accu2i pMTA along the line he intended to cut in order to minimise blood loss. In total he conducted six 120 watt, two minute burns.

Dr Legaspi then proceeded to cut out the lesion with minimal blood loss while carrying out three further two minute burns at 180 watts. At the end of the operation the removed tissue measured approximately 5.5cm, providing an excellent margin, and the collection canister was empty, with only trace amounts of blood in the suction tubing. In total, the patient was in theatre for two and half hours.

After the case Dr Legaspi said: “I feel that the capability of pre-coagulation with microwave ablation for robotic surgery is going to help reduce operative time and improve patient outcomes.”

Stuart McIntyre, Chief Executive of Microsulis Medical Ltd, said: “We are delighted that the versatility of the Accu2i pMTA applicator has been highlighted as part of this technologically advanced, minimally invasive procedure.”

The Accu2i pMTA applicator – part of the Acculis Microwave Tissue Ablation (MTA) system - is the most powerful soft tissue ablation product available, combining extreme ease of use with the widest range of clinical applications. It is a single high power, high frequency 2.45GHz, saline-cooled needle that is between three to 10 times faster than other devices. It can coagulate tissue masses of up to 5.6cm in size in just six minutes.

Mount Sinai Medical Center is the largest private independent teaching hospital in South Florida and has used Microsulis Medical’s Acculis MTA system since April 2011.

Dr Legaspi is working on a full write up of this liver resection case for publication in the near future.

Microsulis’ microwave tissue ablation devices have been used in more than 100 hospitals world-wide. For more information, go to: www.microsulis.com.

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About Microsulis Medical

Notes for editors

Images of the da Vinci Surgical System are available to download from the Intuitive Surgical website: http://www.intuitivesurgical.com/.

Microsulis Medical to sponsor liver conference exploring advances in medical and surgical interventions

Wed, 19 Jun 2013 16:25:18 +0100

Microsulis Medical to sponsor liver conference exploring advances in medical and surgical interventions

DENMEAD, ENGLAND - Monday November 28, 2011: Microsulis Medical Ltd, the specialist in microwave tissue ablation, is a major sponsor of the forthcoming Carolinas Medical Center’s 5th Annual Liver Conference, ‘Advances in Medical and Surgical Interventions for GI and HPB Diseases’.

The event, which will be attended by approximately 150 US and international clinicians, includes a session on minimally invasive HepatoPancreaticoBiliary surgery, focusing on cases using intra-operative ultrasound and laparoscopic techniques.

Microsulis Medical specializes in devices for percutaneous and laparoscopic soft tissue ablation. Its Accu2i pMTA applicator – part of the Acculis Microwave Tissue Ablation (MTA) system - is a single high power, high frequency 2.45GHz, saline-cooled needle that is between three to 10 times faster than other devices. Clinicians insert the needle through a puncture in the skin or surgical incision to reach internal organs or tissue. It is then activated and can coagulate tissue masses up to 5.6cm in size in just six minutes. Progress can be monitored via Ultrasound, CT imaging or visually.

Dr David Iannitti, Course Director and Chief, Hepato-Pancreato-Biliary Surgery at Carolinas Medical Center, Charlotte, North Carolina, said: “We are greatly looking forward to the upcoming conference, which promises to be an excellent comprehensive program featuring advances in laparoscopic liver surgery and microwave ablation.”

Stuart McIntyre, Chief Executive of Microsulis Medical, said: “We are delighted to be supporting this academic event and look forward to sharing our innovative ablation technology with the surgical community.”

The conference takes place at the Ballantyne Hotel and Lodge in Charlotte, North Carolina, on Saturday December 3. Speakers include Professor Derek Raghavan, President of the Levine Cancer Institute, and Dr David Geller, Co-director of the UPMC Liver Cancer Centre, University of Pittsburgh.

Microsulis’ microwave tissue ablation devices have been used in more than 100 hospitals world-wide. For more information, go to: www.microsulis.com.

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About Microsulis Medical

Technological advances promise new treatment options for lung and pancreatic cancers

Wed, 19 Jun 2013 16:25:18 +0100

Technological advances promise new treatment options for lung and pancreatic cancers

DENMEAD, ENGLAND - Tuesday November 22, 2011: Microsulis Medical Ltd, the specialist in microwave tissue ablation, is investigating new treatment technology for patients diagnosed with lung and pancreatic diseases.

The announcement comes as Macmillan Cancer Support released new data today showing that, up to 2007, median cancer survival periods in England and Wales had improved six fold in the past four decades*. However, the data also showed a major lack of progress for some disease types including lung and pancreatic cancer.

Hampshire-based Microsulis Medical is the UK’s only specialist in needle-like devices that use microwave energy to destroy diseased soft tissue. During the past three years, clinicians have used the Acculis Microwave Tissue Ablation (MTA) system to treat cancers of the liver, lung, kidney and bone tissues. As part of its continuing product innovation plan, Microsulis is supporting further research into developing its devices' use in lung procedures. In addition, it is working on a procedural protocol for pancreatic treatments.

Stuart McIntyre, Chief Executive of Microsulis Medical, said: “Our system has been in commercial use for nearly three years and the feedback we have had from surgeons and radiologists has been extremely positive. They used our device to treat patients that might have otherwise been inoperable, giving them a valuable treatment option.

“We are continuing to support research into the use of our Acculis MTA system, in particular new high frequency versions, and hope it will make a positive contribution to improving cancer survival periods in the future.”

A key element of the Acculis MTA system is the Accu2i pMTA applicator. It is a single high power, high frequency 2.45GHz, saline-cooled needle that is between three to 10 times faster at treating soft tissue than other devices. Clinicians insert the needle through a puncture in the skin, also known as a percutaneous procedure, to reach internal organs or tissue. It is then activated and can coagulate tissue masses up to 5.6cm in size in just six minutes.

Microsulis’ microwave tissue ablation devices have been used in more than 100 hospitals world-wide. For more information, go to: www.microsulis.com.

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Notes to editors

*Source: The Cancer Survival Lottery, Macmillan Cancer Support

About Microsulis Medical

Microsulis Medicalâ��s microwave tissue ablation system promoted to imaging nurses in the southern hemisphere

Wed, 19 Jun 2013 16:25:18 +0100

DENMEAD. ENGLAND – November 14, 2011: The benefits of Microsulis Medical Ltd’s Acculis Microwave Tissue Ablation (MTA) system were presented at the recent Medical Imaging Nurses Association (MINA) national meeting in Adelaide, Australia.

The conference for Australian and New Zealand medical imaging nurses was attended by more than 200 delegates from across both countries.

Registered Nurse Amie Smith, from the Medical Imaging Department at Flinders Medical Centre, Adelaide, spoke about the hospital’s use of the Acculis MTA system, which includes a range of needle-like applicators for the coagulation of soft tissue.

Flinders bought the system a year ago and has carried out more than 20 hepatocarcinoma cases using CT and three cases laparoscopically using intraoperative ultrasound.

RN Smith discussed the selection criteria used at Flinders to determine patient suitability, as well as the pre-operative work up, and pre and post-op care required for patients undergoing this procedure. To date, all of the cases performed at Flinders have been conducted under general anaesthesia, with day or short stay patients.

The Acculis MTA’s premier product, the Accu2i percutaneous MTA (pMTA) applicator, is the most powerful soft tissue ablation needle available, combining extreme ease of use with the widest range of clinical applications. It is a single high power, high frequency 2.45GHz, saline-cooled needle that is between three to 10 times faster than other devices. It can coagulate tissue masses of up to 5.6cm in size in just six minutes.

Microsulis Medical’s MTA system has been used in more than 100 hospitals world-wide. For more information, go to: www.microsulis.com.

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About Microsulis Medical

We are a specialist medical device company with market leading, game changing solutions in microwave ablation. Our products deliver significant technological and clinical advances to physicians and patients in minimally invasive, soft tissue ablation. The Accu2i pMTA applicator was CE-marked in February 2010, FDA 510(k) cleared in August 2010, approved for use in Australia and New Zealand in August 2010, and gained a Health Canada license in January 2011. For more information about the Acculis MTA system, visit www.microsulis.com.

Microwave showcase to explore ablation techniques

Wed, 19 Jun 2013 16:25:18 +0100

Microwave showcase to explore ablation techniques

DENMEAD, UK – Monday October 31, 2011: UK-based medical device manufacturers Microsulis Medical Ltd will host a workshop on microwave ablation on day one of this year’s British Society of Interventional Radiology (BSIR) annual meeting.

Microwave is the newest ablative tool available to clinicians, bringing with it the option to improve outcomes for patients who do not qualify for other procedures and reduce treatment costs for hospitals. At this year’s BSIR, clinicians are being invited to hear the experiences of colleagues who have used this technology.

Like RFA, microwave energy can be used to coagulate unhealthy soft tissue without the need to remove it surgically. In practice, radiologists have found microwave ablation is fast, precise and simple to use. Many more sites can be coagulated in a given operative window. In addition, the coagulation zone can also be monitored in real time using ultrasound or CT imaging, allowing radiologists to reliably achieve the desired margins.

Microsulis’ technological workshop is being held to share the techniques clinicians have used to optimise treatment outcomes using microwave technology. The event will be facilitated by Dr Graham Plant, Interventional Radiologist from North Hampshire Hospital in Basingstoke.

Dr Plant will draw together experience in microwave ablation techniques to treat tumours of the liver and lung. The event is open to BSIR delegates and will take place at the SECC on Wednesday November 2.

Microsulis Medical is exhibiting at BSIR Stand M27.

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About Microsulis Medical

Microsulis Medical’s Accu2i pMTA applicator is the most powerful soft tissue ablation product available, combining extreme ease of use with the widest range of clinical applications. It is a single high power, high frequency 2.45GHz, saline-cooled needle that is between three to 10 times faster than other devices. It can coagulate tissue masses up to 5.6cm in size in just six minutes.

The Accu2i pMTA applicator was CE-marked in February 2010, FDA 510(k) cleared in August 2010, approved for use in Australia and New Zealand in August 2010, and gained a Health Canada license in January 2011. For more information about the Acculis MTA system visit www.microsulis.com.

You can find Microsulis Medical on Twitter, Facebook and LinkedIn.

The MTA system receives approval to use international safety mark

Wed, 19 Jun 2013 16:25:18 +0100

Microsulis Medical’s microwave ablation system receives approval to use internationally recognised safety mark

DENMEAD, ENGLAND – Monday October 17, 2011: Microsulis Medical Ltd has received approval to apply the ETL safety mark to its Acculis microwave tissue ablation (MTA) system. This innovative technology has already been successfully commercialised in Europe and North America, and is being rolled out to the rest of the world.

The ETL Mark independently verifies compliance with international safety standards, and is recognised world-wide. This accreditation mark will now appear on Microsulis Medical’s Sulis VpMTA Generator, which powers the Acculis range of microwave tissue ablation devices.

Stuart McIntyre, Microsulis Medical’s Chief Executive, said: “We are pleased to apply this standard to our products. The ETL mark is a trusted accreditation, which will underpin commercialisation of our innovative technology in emerging markets.”

Microsulis Medical specialises in minimally invasive, soft tissue ablation devices utilising microwave technology. The company’s leading product is the Accu2i pMTA applicator, which is a needle-like device that has been used by clinicians to treat tumours of the liver, lung, kidneys and bone. This device was CE-marked in February 2010, FDA 510(k) cleared in August 2010, approved for use in Australia and New Zealand in August 2010, and gained a Health Canada licence in January 2011.

The Acculis MTA system, including the Sulis VpMTA Generator, has been used in more than 100 medical centres world-wide. For more information about the Acculis MTA system, visit www.microsulis.com.

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Notes to editors

For more information about the ETL Mark see www.intertek.com/marks/etl/.

You can find Microsulis Medical on Twitter, Facebook and LinkedIn.

Effective microwave ablation techniques highlighted at Asian-Pacific surgical conference

Wed, 19 Jun 2013 16:25:18 +0100

Effective microwave ablation techniques highlighted at Asian-Pacific surgical conference

DENMEAD, ENGLAND – October 10, 2011 - The effectiveness of microwave ablation in surgery was highlighted at the recent Asian Pacific Hepato-Pancreato-Biliary Association (APHPBA) Congress in Melbourne, Australia.

Leading clinicians presented their findings at a symposium hosted by Platinum congress sponsors, Microsulis Medical Ltd - the specialist in microwave ablation devices. APHPBA is the premier event for clinicians in the southern hemisphere and this year was attended by 849 delegates.

The symposium – ‘Microwave: effective ablation, supporting surgery’ – was moderated by senior liver surgery professors from the University of Edinburgh, Royal Infirmary Edinburgh, in the UK and Hopital Beaujon in Paris, France. More than 100 delegates were in attendance.

Presentations during the session focused on both the technical and histopathological aspects of microwave ablation. In particular, clinicians from the USA, Europe and Asia shared their clinical experiences and data from using Microsulis Medical’s Accu2i pMTA applicator – part of the Acculis microwave tissue ablation (MTA) system.

Stuart McIntyre, Microsulis Medical’s Chief Executive, said: “It was valuable to share how the Acculis MTA system is being used at centres around the world. APHPBA delegates heard reports of clinical outcomes and data from primary liver cancer procedures performed during open and laproscopic surgery.”

Microsulis Medical’s microwave tissue ablation devices have been used in more than 100 hospitals world-wide. For more information, go to: www.microsulis.com.

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About Microsulis Medical

We are a specialist medical device company with market leading, game changing solutions in microwave ablation. Our products deliver significant technological and clinical advances to physicians and patients in minimally invasive, soft tissue ablation. The Accu2i pMTA applicator was CE-marked in February 2010, FDA 510(k) cleared in August 2010, approved for use in Australia and New Zealand in August 2010, and gained a Health Canada license in January 2011. For more information about the Acculis MTA system visit www.microsulis.com.

Â£250,000 manufacturing facility opens

Wed, 19 Jun 2013 16:25:18 +0100

Microsulis Medical Ltd opens £250,000 manufacturing facility in the UK

DENMEAD, ENGLAND – September 6: Medical device developer, Microsulis Medical Ltd, has invested £250,000 in a new in-house production and packaging facility, increasing its manufacturing capacity.

Over the summer, controlled clean-room production and packaging environments, measuring 80sqm, were installed at the company’s headquarters in Denmead, England.

The opening of the new facility comes just weeks after Microsulis announced a $15m funding round for the commercialisation of its Accu2i pMTA applicator for microwave tissue ablation. The investment will be used to support growing sales in Canada, South Africa, Australia and New Zealand, and expand into the Eastern Europe, Indian, Asian and South American markets. By 2016, Microsulis is targeting growth beyond $50m in revenue income.

CEO Stuart McIntyre, said: “This new facility will allow for a substantial boost in yield to meet increased product demand around the world. We already have a strong customer base in the UK, Europe and USA, and extra productivity and investment will allow us to expand both within those markets and beyond.”

The new clean-room production environment will manufacture the Accu2i pMTA applicator, which is the most powerful soft tissue ablation product available. It is a single high power, high frequency 2.45GHz, saline-cooled needle that is between three to 10 times faster than other devices. Doctors insert the needle through a puncture in the skin, also known as a percutaneous procedure, to reach internal organs or tissue. It is then activated and can coagulate, or destroy tissue, masses up to 5.6cm in size in just six minutes. Clinicians have successfully used microwave energy to treat cancerous lesions or tumours in the liver, lung, kidney and bone.

Key features of the new Microsulis production area include:

• a flexible manufacturing layout, including a bespoke six-axis, automated dipping machine for coating the Accu2i pMTA with a high performing, silicone elastomer

• high lighting levels for fine detail work

• and, a high quality positive pressure air filtration system to maintain a clean manufacturing environment.

The facility will also be used as a development area for future product activities using Microsulis platform technology.

Microsulis’ microwave tissue ablation devices have been used in more than 100 hospitals world-wide. For more information, go to: www.microsulis.com.

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About Microsulis Medical

We are a specialist medical device company with market leading, game changing solutions in microwave ablation. Our products deliver significant technological and clinical advances to physicians and patients in minimally invasive, soft tissue ablation. The Accu2i pMTA applicator was CE-marked in February 2010, FDA 510(k) cleared in August 2010, approved for use in Australia and New Zealand in August 2010, and gained a Health Canada license in January 2011. For more information about the Acculis MTA system visit www.microsulis.com.

$15m commercialisation of Accu2i pMTA

Wed, 19 Jun 2013 16:25:18 +0100

Microsulis Medical announces $15m commercialisation of its innovative microwave ablation technology

DENMEAD, ENGLAND - August 17, 2011: Microsulis Medical Ltd (www.microsulis.com), the specialist in microwave ablation technology, has announced a funding round worth up to $15m for the global commercialisation of its percutaneous device - the Accu2i pMTA applicator. More than $6m has already been committed by existing shareholder RMC Capital, with other investors being invited to participate.

The Accu2i pMTA applicator is the most powerful soft tissue ablation product available, combining extreme ease of use with the widest range of clinical applications. It is a single high power, high frequency 2.45GHz, saline-cooled needle that is between three to 10 times faster than other devices. It can coagulate tissue masses up to 5.6cm in size in just six minutes.

Initial market testing has seen over 100 systems installed worldwide with substantial uptake by interventional radiologists and surgeons, especially in the treatment of liver and lung tissues.

Stuart McIntyre, Chief Executive and shareholder, said: “Our market leading products are already bringing significant benefits to physicians and patients in the UK, US and Europe. Now is the time for us to invest and take this ground-breaking technology global. We have established strong initial distribution structures with direct sales in the USA and Europe along with a growing group of distributors and agents worldwide. Complementing this we have established our internal manufacturing facility which will provide additional capacity as volumes grow.”

Microsulis already has a strong customer base for its specialist oncology devices in the UK, Europe and USA, with growing sales in Canada, South Africa, Australia and New Zealand. It is targeting growth beyond $50m in revenue income by 2016 as it carries out strategic expansion from the US and Western Europe into the Eastern Europe, Indian, Asian and South American markets.

In order to meet growing demand for this advanced technology, Microsulis will establish further manufacturing capacity beyond the UK as needed and increase its commercial team to cover new markets. There are also plans for extensive clinical analysis with the Accu2i pMTA applicator, in order to evidence its favourable performance against radio-frequency, cryoablation and other less powerful microwave devices. New international registrations will follow.

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About Microsulis Medical

We are a specialist medical device company with market leading, game changing solutions in microwave ablation. Our products deliver significant technological and clinical advances to physicians and patients in minimally invasive, soft tissue ablation. The Accu2i pMTA applicator was CE-marked in February 2010, FDA 510(k) cleared in August 2010, approved for use in Australia and New Zealand in August 2010, and gained a Health Canada license in January 2011. For more information about the Acculis MTA system visit www.microsulis.com or call +44 (0)2392 240011.

Microsulis joins the social network

Wed, 19 Jun 2013 16:25:18 +0100

Microsulis Medical joins the social network

Microsulis Medical, the market leader in medical devices for microwave ablation of soft tissue, such as cancerous tumours, has launched two social networking profiles to help it keep in touch with its customers. You can now keep up to date with the latest developments at Microsulis Medical by following the company on Twitter and liking it on Facebook.

New distributor for Australia

Wed, 19 Jun 2013 16:25:18 +0100

Microsulis Medical forges partnership with N. Stenning & Co. for distribution of its microwave ablation system in Australia and New Zealand

DENMEAD, ENGLAND - July 4, 2011 - Microsulis Medical Ltd has announced the appointment of N. Stenning & Co. as the distributor of its groundbreaking Acculis Microwave Tissue Ablation (MTA) system (www.acculis.com) in Australia and New Zealand. The partnership brings together the market leader in microwave ablation technology for oncology applications and one of the region’s most highly regarded medical device distributors.

N. Stenning & Co. has been a distributor of innovative, high quality medical devices for nearly 60 years. It offers Australia-wide coverage, with offices in Sydney, Melbourne, Brisbane, Adelaide and Perth, and has established links with medical facilities in New Zealand. This, combined with its commitment to providing excellent clinical and customer support, has made it the perfect partner for Microsulis in the southern hemisphere.

Microsulis placed its first Acculis MTA system in Australia in April 2008 and has since developed a strong customer base across five hospitals in the region. The agreement with N. Stenning & Co. has been formed at a time when Microsulis is enjoying a period of growth in this important market thanks to an enthusiastic reception from surgeons and radiologists.

Stuart McIntyre, Chief Executive of Microsulis, said: “Feedback from our Australian and New Zealand customers has been extremely positive. We are delighted to now be in a position to offer this advanced device to the wider market through a competent and trusted company.”

“Our Acculis range supersedes all other tissue ablation technology. Its unique design allows for shorter treatment times, precise control of microwave energy and larger coagulation areas using a single applicator. This provides a wider choice of treatment options to patients whose conditions might have previously been inoperable.”

The Acculis system operates at 2.45GHz and is the most powerful device on the market when compared to Radio Frequency Ablation (RFA) devices and low power microwave systems. The premier product in the range is the Accu2i pMTA. This applicator is capable of delivering coagulation zones of up to 5.6cm in six minutes.

Flinders Medical Centre in Adelaide has used the MTA system to ablate more than 20 tumours in open and percutanous guided procedures since the beginning of 2011. Dr John Chen, Senior Consultant Surgeon said: “We have mainly used the MTA system for the treatment of liver cancers. Our initial experience has been good. The size and speed of ablation, combined with the simplicity of the system, sets this product apart. It is also safer for patients, as it reduces the risk of serious complications.”

Gordon Stenning Managing Director of N Stenning & Co, said “We are delighted to be representing the Acculis MTA system, an innovative product technology for improved patient outcomes.”

The Acculis MTA system is FDA cleared and CE marked. It is currently in use in more than 80 hospitals and medical centres worldwide.

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About Microsulis Medical

Microsulis Medical is a specialist medical device company developing microwave energy ablation technology for oncology applications. The Acculis Microwave Tissue Ablation (MTA) system is a new product for the coagulation of soft tissue. The system is currently in commercial use in leading institutions in the UK, Europe, USA, Canada and Asia. Microsulis is based in Hampshire, UK. For more information about the Acculis MTA system visit www.acculis.com or call +44 (0)2392 240011.

WCIO microwave symposium success

Wed, 19 Jun 2013 16:25:18 +0100

WCIO microwave symposium success

DENMEAD, ENGLAND - June 15, 2011 - Microsulis Medical's microwave ablation symposium attracted more than 100 delegates at the World Conference on Interventional Oncology held in New York last week (9-12 June).

Speaking were five of the world's leading authorities on oncological ablation:

Professor S. Nahum Goldberg MD, FSIR, Section Chief of Imaged Therapy at Hadassah Hebrew University Medical Center, Jerusalem, Israel - ‘Microwave Ablation: Basic Principles and Evaluation Criteria’
Dr David Iannitti MD, Professor of Surgery and Chief Hepato-Pancreato-Biliary Surgery at Carolinas Medical Center, North Carolina - ‘The Collective Experience of Microwave Ablation in Liver’
Dr Mark Anderson MD, Churchill Hospital, Oxford, United Kingdom – ‘Multiple Applications of the New pMTA System’
Dr David Breen MD, Consultant Abdominal Radiologist and Honorary Senior Lecturer in Radiology, Southampton University Hospitals, Southampton, United Kingdom – ‘Microwave ablation in the Liver: Lessons learnt at 2.45GHz’
Dr Darin Furgeson PhD, Assistant Professor of Pharmaceutics and Pharmaceutical Chemistry, Adjunct Assistant Professor of Pediatrics, Chemical and Biomedical Engineering at University of Utah, Salt Lake City, Utah – ‘Cleaning Dirty Tumor Margins with Thermo-targeted Chemotherapy and Microwave Ablation’.

Microsulis’ Acculis Microwave Tissue Ablation (MTA) system has been in distribution since 2008 and is now being used in more than 80 hospitals and medical centers worldwide. The Acculis system operates at 2.45GHz and is the most powerful device on the market when compared to Radio Frequency Ablation (RFA) devices and low power 915MHz microwave systems. The benefits this more advanced technology brings for patients, surgeons and hospitals include shorter treatment times, precise control of microwave energy and larger coagulation areas using a single applicator.

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About Microsulis Medical

Microsulis Medical is a specialist medical device company developing microwave energy ablation technology for oncology applications. The Acculis Microwave Tissue Ablation (MTA) system is a new product for the coagulation of soft tissue. The system is currently in commercial use in leading institutions in the UK, Europe, USA and Asia. Microsulis is based in Hampshire, UK. For more information about the Acculis MTA system visit www.acculis.com or call +44 (0)2392 240011.

Microsulis symposium at WCIO

Wed, 19 Jun 2013 16:25:18 +0100

Microsulis Medical to sponsor Microwave Ablation Symposium at the World Conference on Interventional Oncology (WCIO)

DENMEAD, ENGLAND - June 3, 2011 - Microsulis Medical (www.Microsulis.com), the market leader in microwave ablation technology, is sponsoring a key symposium on groundbreaking microwave ablation technology at WCIO - the premier international and multidisciplinary meeting for image guided cancer therapies - June 9-12. Speaking at the symposium at the Sheraton New York Hotel and Towers on June 9 will be five of the world’s leading authorities on oncological ablation.

Co-moderating the Microwave Ablation Dinner Symposium will be Professor S. Nahum Goldberg MD, FSIR, Section Chief of Imaged Therapy at Hadassah Hebrew University Medical Center, Jerusalem, Israel, and Dr David Iannitti MD, Professor of Surgery and Chief Hepato-Pancreato-Biliary Surgery at Carolinas Medical Center, North Carolina. They will be joined by a panel of expert speakers who will investigate the uses, experiences and results of microwave ablation. The presentations will be followed by a panel discussion with conference delegates. The speakers and presentations include:

Prof Goldberg – ‘Microwave Ablation: Basic Principles and Evaluation Criteria’
Dr Iannitti – ‘The Collective Experience of Microwave Ablation in Liver’
Dr Mark Anderson MD, Churchill Hospital, Oxford, United Kingdom – ‘Multiple Applications of the New pMTA System’
Dr David Breen MD, Consultant Abdominal Radiologist and Honorary Senior Lecturer in Radiology, Southampton University Hospitals, Southampton, United Kingdom – ‘Microwave ablation in the Liver: Lessons learnt at 2.45GHz’
Dr Darin Furgeson PhD, Assistant Professor of Pharmaceutics and Pharmaceutical Chemistry, Adjunct Assistant Professor of Pediatrics, Chemical and Biomedical Engineering at University of Utah, Salt Lake City, Utah – ‘Cleaning Dirty Tumor Margins with Thermo-targeted Chemotherapy and Microwave Ablation’.

Microsulis’ Acculis Microwave Tissue Ablation (MTA) system has been in distribution since 2008 and is now being used in more than 80 hospitals and medical centres worldwide. The Acculis system operates at 2.45GHz and is the most powerful device on the market when compared to Radio Frequency Ablation (RFA) devices and low power 915MHz microwave systems. The benefits this more advanced technology brings for patients, surgeons and hospitals include shorter treatment times, precise control of microwave energy and larger coagulation areas using a single applicator.

Microsulis Medical will be exhibiting its premier product, the US Food and Drug Administration (FDA) cleared Acculis Accu2i percutaneous microwave tissue ablation applicator (pMTA), at Booth 500 throughout WCIO.

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About Microsulis Medical

Microsulis Medical is a specialist medical device company developing microwave energy ablation technology for oncology applications. The Acculis Microwave Tissue Ablation (MTA) system is a new product for the coagulation of soft tissue. The system is currently in commercial use in leading institutions in the UK, Europe, USA and Asia. Microsulis is based in Hampshire, UK. For more information about the Acculis MTA system visit www.acculis.com or call +44 (0)2392 240011.

Health Canada approval for Accu2i pMTA

Wed, 19 Jun 2013 16:25:18 +0100

Microsulis Medical Limited Receives Health Canada Approval of the Accu2i Percutaneous Microwave Tissue Ablation Device

DENMEAD, ENGLAND - January 31, 2011 - Microsulis Medical Limited, the leading company in microwave technology for medical devices, today announced that it has received approval from Health Canada for the Acculis Accu2i percutaneous microwave tissue ablation (pMTA) system for the coagulation of soft tissue during surgical procedures. The system has already been in use in Europe and the United States treating liver and lung tumors via a small 1.8 mm needle puncture of the skin. This groundbreaking treatment allows physicians to apply precise microwave energy to remove unwanted tissue masses whilst avoiding the risks associated with longer, more invasive surgical interventions.

The Accu2i pMTA system is now cleared in Europe, the United States, and Canada and it delivers 2.45 GHz of power to coagulate unwanted tissue masses. The design consists of a 1.8 mm diameter closed water cooled needle that allows physicians to coagulate large tissue volumes in minutes. The system is unique in that it uses specialized patented microwave antenna designs that achieve the very high levels of microwave energy deposition into tissue needed to quickly and effectively coagulate unwanted areas of soft tissue.

“The Health Canada approval builds on the momentum we experienced in 2010 with the CE mark and FDA clearance of the Accu2i pMTA system,” said Stuart McIntyre, CEO of Microsulis Medical Limited. “We are pleased to have received this approval from Health Canada for the pMTA system so physicians can begin to offer this game changing treatment option for patients in Canada.”

First U.S. patient treated with pMTA

Wed, 19 Jun 2013 16:25:18 +0100

First U.S. patient treated with the Accu2i Percutaneous Microwave Tissue ablation device (pMTA)

DENMEAD, ENGLAND—DECEMBER 6, 2010—Microsulis Medical Limited, the leading company in microwave technology for medical devices, today announced that the first U.S. patient was treated with the company’s Accu2i percutaneous microwave tissue ablation (pMTA) system. The Accu2i pMTA system, which is now in worldwide distribution, is indicated for the coagulation of localised soft tissue during surgical procedures and recently received U.S. Food and Drug Administration (FDA) clearance.

The procedure involved a patient with hepatocellular carcinoma (HCC), or primary liver cancer, and was performed by Dr. N. Joseph Espat, Professor and Chief, Surgical Hepatobiliary Oncology at Roger Williams Medical Center, Boston University. During the procedure, Dr. Espat combined microwave ablation using the Accu2i pMTA System of one 3cm tumor with surgical resection of two additional tumors.

“The device performed beyond my expectations - it was faster and better than the previous MTA system,” said Dr. N. Joseph Espat, Professor and Chief, Surgical Hepatobiliary Oncology at Roger Williams Medical Center, Boston University. “The pMTA system is easier to handle and the diameter of the antenna makes it very safe. The tumor ablation was more rapid and efficient as compared to any other monopolar RFA system I’ve used previously. I’m pleased that Roger Williams Medical Center continues to be a technology leader for the treatment of patients with complex liver tumors.”

Liver cancer is the third most common cancer in the world and will kill almost all patients who have it within a year. According to the American Cancer Society, the incidence of liver cancer has been steadily increasing, along with death rates, since the early 1980s. More than 80 percent of all new liver cancer cases diagnosed are Hepatocellular Carcinoma (HCC). The 5-year relative survival rate for patients with liver cancer is 14 percent. Five-year survival is 26 percent among patients in whom cancer is found at an early stage, compared to only 2 percent when it is found after spreading to distant organs (Cancer Facts & Figures 2010, American Cancer Society).

“We are delighted to report the first pMTA case in the United States and consider it a milestone in providing a sophisticated, fast and effective method for ablating unwanted tissue masses,” said Stuart McIntyre, CEO of Microsulis Medical Limited. “Current RFA and microwave systems have proven to have certain limitations when it comes to treating large and numerous soft tissue masses. With the Accu2i, surgeons and radiologists can now perform larger and faster ablations that are suitable and less invasive for a broader group of patients.”

Historically, treatment options for liver cancer have included one or a combination of treatments including surgical removal of the cancer, chemotherapy, radiofrequency ablation (RFA), or radiation therapy. Ablative therapies, which aim to destroy tumors in-situ, are limited by the number and size of the tumors that can be targeted, therefore eliminating them as an option in many cases due to the limited performance of existing RFA and microwave systems. However, the Acculis Accu2i pMTA system is the first high power 2.45 GHz system that enables larger and faster ablations to be performed. This means that ablative therapy will now be available as an option for many more patients.

Microsulis' Acculis pMTA is FDA Cleared

Wed, 19 Jun 2013 16:25:18 +0100

Microsulis Medical Limited receives FDA 510(k) clearance of Accu2i Percutaneous Microwave Tissue Ablation Device

High Power Microwave Tissue Ablation System Used to Destroy Liver and Lung Tumors

DENMEAD, England - August 12, 2010 - Microsulis Medical Limited, the leading company in microwave technology for medical devices, today announced that the U.S. Food and Drug Administration (FDA) has provided the company 510(k) clearance to market the Acculis Accu2i percutaneous microwave tissue ablation (pMTA) system for the coagulation of soft tissue during surgical procedures. This innovative treatment allows physicians to apply precise microwave energy to ablate unwanted tissue masses. The system has already been in use in Europe treating liver and lung tumors via a small 1.8 mm needle puncture of the skin. By providing an alternative to “open surgery” patients avoid the risks associated with longer, more invasive surgical interventions.

“The Accu2i pMTA system allows physicians to deliver precise microwave energy to treat tumors up to 5cm in size in a very short period of time. It will add a significant additional tool into the armamentarium of oncologists, surgeons and radiologists treating patients with this illness.”

“We are delighted to receive this clearance from the FDA and are looking forward to introducing the pMTA product to the U.S. market after seeing its success throughout Europe. Having transferred the product to the manufacturer in Europe we now have a system that we know is market-ready and tested,” said Stuart McIntyre, CEO of Microsulis Medical Limited. “Moreover this is the first high power 2.45 GHz system available and sets a new benchmark for such devices.”

According to the American Cancer Society, more than 450,000 Americans suffer from lung and liver cancer annually. Historically treatment options for these types of cancer have included one or a combination of treatments including surgical removal of the cancer, chemotherapy, radiofrequency ablation (RFA), or radiation therapy. Ablative therapies which aim to destroy tumors in-situ are limited by the number and size of the tumors that can be targeted and so it’s not an option in many cases due to the limited performance of existing RFA and microwave systems. However the Acculis Accu2i pMTA system is the first high power 2.45 GHz system that enables larger and faster ablations to be performed. This means that ablative therapy will now be available as an option for many more patients.

“If the clinical performance of the system confirms the early promise of this technology, this advancement will lead to new treatment options for lung and liver cancer patients,” said Dr. William Scott Helton, Chairman, Department of Surgery at Hospital of Saint Raphael, New Haven, Conn. “The Accu2i pMTA system allows physicians to deliver precise microwave energy to treat tumors up to 5cm in size in a very short period of time. It will add a significant additional tool into the armamentarium of oncologists, surgeons and radiologists treating patients with this illness.”

For more information about the Acculis Accu2i pMTA system, visit www.acculis.com.