Exogenesis said yesterday that it won FDA 510(k) clearance for its hernia mesh implant for soft tissue repair in abdominal wall hernias and deficiencies.
The Exogenesis mesh is made from polypropylene fibers warp-knitted together to create a device with large pores and minimum density and thickness, similar to current meshes on the market. It’s designed to allow tissue ingrowth to reinforce the hernia or defect. The mesh is also designed to minimize inflammatory response and fibrous encapsulation.
Exogenesis said its mesh has favorable post-implant tissue compatibility, thanks to accelerated neutral atom beam technology used during manufacturing. The Billerica, Mass.-based company said medical implants treated with ANAB technology have recently been granted FDA clearance for use in spinal interbody fusion devices as well.
“We are thrilled to receive FDA clearance of the Exogenesis hernia mesh premarket application,” president & CEO Dmitry Shashkov said in prepared remarks. “We are currently completing commercial channel development for this novel product and look forward to bringing it to the clinical community in the near future.”
“Advances in mesh technology are critical to further improving patient outcomes in hernia repair,” added New England Hernia Center director Dr. David Earle. “I see surface modification at the nanoscale as one of the most important recent technological advances. Exogenesis’ FDA clearance is a crucial step in this direction.”