PolyTouch Medical, a developer of laparoscopic hernia mesh placement technologies, has filed a Premarket 510(k) Application (PMA) with the FDA for PatchAssist, a laparoscopic mesh deployment and placement device that enables accurate mesh placement in laparoscopic ventral hernia repair potentially reducing procedure time by 30%-50%.
PolyTouch Medical said that the 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.
Ofek Levin, founder and CEO of PolyTouch Medical, said: “We are extremely excited to have reached this value-creating milestone with the filing of a Premarket 510(k) Application for PatchAssist. LVHR is a relatively complicated laparoscopic procedure mainly due to the hurdle of mesh deployment and placement stage.
“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, assistant professor of surgery at Tufts University School of Medicine and medical advisor PolyTouch, said: “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.”