PolyTouch Medical files Premarket 510(k) application for PatchAssist laparoscopic mesh deployment device

May 3 2010

PolyTouch Medical Ltd., a leading developer of laparoscopic hernia mesh placement technologies, today announced that it has filed a Premarket 510(k) Application with the US Food and Drug Administration for PatchAssist, an Innovative Laparoscopic Mesh Deployment and Placement Device that enables accurate mesh placement in laparoscopic ventral hernia repair potentially reducing procedure time by 30%-50%.

PatchAssist is a standalone surgical mesh placement device that is compatible with all common hernia meshes and supports a wide span of mesh sizes including the largest mesh sizes in the market. PatchAssist enables surgeons to choose their preferred mesh during LVHR procedures.

"We are extremely excited to have reached this value-creating milestone with the filing of a Premarket 510(k) Application for PatchAssist," said Ofek Levin, Founder and CEO of PolyTouch Medical. "LVHR is a relatively complicated laparoscopic procedure mainly due to the hurdle of mesh deployment and placement stage. With over 400,000 annual ventral hernia repair procedures in the US, and with laparoscopic surgeries growing over 21% annually, we believe that PatchAssist will become the standard of care in LVHR, will reduce operation time and costs, and will enable an easier and shorter learning curve for surgeons who wish to convert from the open technique to the laparoscopic repair. We are receiving strong indications from surgeons, at all levels of experience, that the product answers a clear clinical need and that they look forward to using this device once it is cleared." Mr. Levin added, "We are currently reviewing several commercial strategies for bringing PatchAssist to market following clearance of the 510(k) pre-market application. Clinical and commercial interest in patch Assist is extremely high. Recent clinical surveys conducted during the American Hernia Society Congress on Orlando last month, suggests that nearly half of surgeons performing LVHR will switch to an alternate surgical mesh if offered with Patch Assist."

David Earle, MD, FACS, Assistant Professor of Surgery, Tufts University School of Medicine, PolyTouch's Medical Advisor commented: "When I first saw the device, I was intrigued. It had the potential to really improve the way both specialists and general surgeons perform laparoscopic hernia repair. When I first used the device, I was convinced."