MISGAV, Israel, May 3, 2010 PolyTouch Medical Ltd., aleading developer of laparoscopic hernia mesh placement technologies, todayannounced that it has filed a Premarket 510(k) Application with the US Foodand Drug Administration for PatchAssist, an Innovative Laparoscopic MeshDeployment and Placement Device that enables accurate mesh placement inlaparoscopic ventral hernia repair potentially reducing procedure time by30%-50%.
PatchAssist is a standalone surgical mesh placement device that iscompatible with all common hernia meshes and supports a wide span of meshsizes including the largest mesh sizes in the market. PatchAssist enablessurgeons to choose their preferred mesh during LVHR procedures.
"We are extremely excited to have reached this value-creating milestonewith the filing of a Premarket 510(k) Application for PatchAssist," said OfekLevin, Founder and CEO of PolyTouch Medical. "LVHR is a relativelycomplicated laparoscopic procedure mainly due to the hurdle of meshdeployment and placement stage. With over 400,000 annual ventral herniarepair procedures in the US, and with laparoscopic surgeries growing over 21%annually, we believe that PatchAssist will become the standard of care inLVHR, will reduce operation time and costs, and will enable an easier andshorter learning curve for surgeons who wish to convert from the opentechnique to the laparoscopic repair. We are receiving strong indicationsfrom surgeons, at all levels of experience, that the product answers a clearclinical need and that they look forward to using this device once it iscleared." Mr. Levin added, "We are currently reviewing several commercialstrategies for bringing PatchAssist to market following clearance of the510(k) pre-market application. Clinical and commercial interest in patchAssist is extremely high. Recent clinical surveys conducted during theAmerican Hernia Society Congress on Orlando last month, suggests that nearlyhalf of surgeons performing LVHR will switch to an alternate surgical mesh ifoffered with Patch Assist."
David Earle, MD, FACS, Assistant Professor of Surgery, Tufts UniversitySchool of Medicine, PolyTouch's Medical Advisor commented: "When I first sawthe device, I was intrigued. It had the potential to really improve the wayboth specialists and general surgeons perform laparoscopic hernia repair.When I first used the device, I was convinced."
As previously reported, PolyTouch announced on April 26th, theappointment of Karl A. LeBlanc, MD, MBA, FACS, as Medical Advisor.Additionally, PolyTouch announced April 12th, the appointment of Morris E.Franklin Jr., MD, FACS, as Medical Advisor. On January 25th, PolyTouchannounced the appointment of William Edelman as Chairman of the Board.
About PolyTouch Medical Ltd.
PolyTouch Medical was founded in March 2009 and is located in the MisgavVenture Accelerator, Israel. Realizing the need for an improved method formesh deployment and placement, PolyTouch has developed PatchAssist (patentspending), a novel and proprietary mesh deployment and placement deviceinitially targeting laparoscopic ventral hernia repair (LVHR). PatchAssist isa standalone surgical mesh placement device that is compatible with allcommon hernia meshes enabling the surgeons to choose their preferred meshduring LVHR procedures and it supports a wide span of mesh sizes includingthe largest mesh size category. PatchAssist enables accurate abdominal cavitymesh placement, potentially reducing procedure time by 30%-50%. PolyTouchplans to introduce the PatchAssist device into the U.S. market in thebeginning of 2011.Contact: Ofek Levin, Founder & CEO PolyTouch Medical Ltd, Email: email@example.com Phone: +972-72-260-7066
SOURCE PolyTouch Medical Ltd.