Covidien has received the US Food and Drug Administration (FDA) 510(k) clearance and CE mark approval for its Parietex Optimized Composite (PCOx) mesh.
PCOx is the next-generation version of Covidien’s Parietex Composite (PCO) mesh which is designed to address surgeon and patient needs in open and laparoscopic ventral hernia repair.
Covidien claims PCOx mesh is more resistant than its PCO, to aid in insertion and placement.
Additionally, the new, proprietary 3-D textile with x-stitch design enables better visibility through the mesh.
Importantly, PCOx has been shown in animals to promote rapid abdominal wall integration, minimize visceral attachments and facilitate strong tack fixation.
A version of PCOx with preplaced sutures that reduces the time needed for traditional suture placement is approved in Europe.
Laparoscopic Surgical Center of New York Brian Jacob said based on PCO’s characteristics, the new PCOx has been enhanced with a more resistant barrier and improved visibility through the mesh, creating an optimal mesh choice for a ventral hernia repair.
The product will be commercially available in the U.S. and Europe starting in June.