PolyTouch Medical, a developer of laparoscopic soft tissue prosthetic placement technologies, has received broad FDA 510(k) clearance to commercialise PatchAssist.
PolyTouch Medical said that the PatchAssist is a laparoscopic surgical instrument that enables delivery and placement of soft tissue prosthetics for a variety of procedures, including laparoscopic ventral hernia repair (LVHR). It is a surgical device that is compatible with all currently commercialized soft tissue prosthetics.
Arik Levy, founder and chief technical officer of PolyTouch, said: “PatchAssist is compatible with all currently commercialized soft tissue prosthetics, a technically challenging design requirement. We are pleased that the FDA has granted broad commercial clearance to PatchAssist.”
Ofek Levin, CEO and founder of PolyTouch Medical, said: “According to the Millennium Research Group, surgeons will perform over 160,000 laparoscopic ventral hernia repair (LVHR) procedures this year in the US. We believe PatchAssist has the potential to shorten the procedure time for all these cases.
“Clinical and commercial interest in PatchAssist is extremely high. Recent clinical surveys conducted during the American Hernia Society Congress in Orlando, suggests that nearly half of surgeons performing LVHR will switch from current to alternate soft tissue Prosthetics if offered with PatchAssist. We are currently considering a number of strategic options to commercialize PatchAssist.”