EMcision Announces 510(k) Clearance Of The Habib EndoHPB, Its Novel Bipolar RF Device For The Palliation Of Biliary And Pancreatic Tumours
EMcision Ltd. today announced clearance for marketing by the United States Food and Drug Administration (K083292) of its Habib™ EndoHPB device for the palliation of biliary and pancreatic tumours.
London (PRWEB) -- EMcision Ltd. today announced clearance for marketing by the United States Food and Drug Administration (K083292) of its Habib™ EndoHPB device for the palliation of biliary and pancreatic tumours.
The Habib™ EndoHPB is an endoscopic bipolar radiofrequency (RF) catheter that allows for:
1) Destruction of biliary tumours prior to stent insertion: Currently, endoscopic plastic stents become clogged by sludge or by tumour pressure narrowing the stent lumen, necessitating regular changing of the stent. Use of the Habib™ EndoHPB prior to stent insertion improves the stent patency by delaying tumour growth.
2) Clearance of obstructed metal stents: Self-expanding mesh metal stents (SEMS), which have longer patency and lower occlusion rates, are still subject to obstructive tumour in-growth. Since SEMS cannot be removed, the Habib™ EndoHPB can be used to ablate the occluding tissue.
"The EndoHPB significantly improves on the procedure for patients suffering from malignant biliary obstruction," stated EMcision's CEO, the internationally renowned surgeon, Professor Nagy Habib. "I am particularly excited about the EndoHPB's application in clearing obstructed metal stents, which represents a real innovation. As a surgeon, I prefer simple and elegant systems and I believe we have achieved that with the EndoHPB. Interventional radiologists and endoscopists who use it tell us they like its convenience and efficacy, and administrators look kindly on the fact that no capital expenditure is required."
The Habib™ EndoHPB is inserted by the interventional radiologist in cases of hilar cholangiocarcinoma or by the endoscopist for tumours in the lower bile duct and head of pancreas. It is a sterile, single-use device compatible with the most commonly used RF generators. The fifth in EMcision's line of medical devices, the EndoHPB is CE marked and has earned considerable positive feedback from its use in clinical settings throughout Europe.
The Company's first product, the Habib™ 4X™, captured close to 30% share of the US hepatic resection market following its introduction under exclusive license to AngioDynamics (NASDAQ: ANGIO). "We expect similar success with the EndoHPB," stated Prof. Habib.
EMcision seeks U.S. distributors to help with this product rollout.
About EMcision:
Founded in 2001 to develop and commercialize clinically relevant and cost-effective medical devices which enhance the quality of patient care, EMcision Limited has introduced a series of innovative proprietary medical devices based on proven RF technology. EMcision's founder, Chairman and CEO Prof. Nagy Habib is also Chair of Surgery and Head of Liver and Pancreatic Surgery at Imperial College London and Hammersmith Hospital. The Company is backed by a group of investors, including the Imperial College University Challenge Seed Fund.
SOURCE: PRWeb
View original release here: http://www.prweb.com/releases/2009/07/prweb2634994.htm