MISGAV, Israel, May 3, 2010 /PRNewswire/ -- 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 comm
|SOURCE PolyTouch Medical Ltd.|
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