Sam Brusco, Associate Editor09.27.22
Mesh Suture Inc. (MSi) has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its DURAMESH non-absorbable polypropylene mesh suture for surgical closure of soft tissues including muscles, fascia, tendons, and ligaments.
The first-of-its-kind device (according to the company) combines the principle of implant incorporation in a mesh repair with placement precision of a suture for soft tissue repairs.
DURAMESH aims to mitigate surgical failure because of suture pull-through. Its architecture flattens at the suture-tissue interface to resist pull-through. An open-walled hollow design allows tissue ingrowth for implant incorporation without capsule formation.
“DURAMESH offers the perfect combination of strength and simplicity in a surgical repair,” Dr. Gregory Dumanian, chief medical officer at MSi told the press. “It combines the handling characteristics of traditional suture with a mesh polyfilament design. We are excited to bring this innovative technology to our surgeon colleagues and to their patients who need it most. By designing DURAMESH to address the surgical complication of suture pull-through, we expect to see sizeable improvements in patient outcomes.”
The DURAMESH suture is already used in the EU and UK, having gained CE mark clearance in Q2 2021.
The first-of-its-kind device (according to the company) combines the principle of implant incorporation in a mesh repair with placement precision of a suture for soft tissue repairs.
DURAMESH aims to mitigate surgical failure because of suture pull-through. Its architecture flattens at the suture-tissue interface to resist pull-through. An open-walled hollow design allows tissue ingrowth for implant incorporation without capsule formation.
“DURAMESH offers the perfect combination of strength and simplicity in a surgical repair,” Dr. Gregory Dumanian, chief medical officer at MSi told the press. “It combines the handling characteristics of traditional suture with a mesh polyfilament design. We are excited to bring this innovative technology to our surgeon colleagues and to their patients who need it most. By designing DURAMESH to address the surgical complication of suture pull-through, we expect to see sizeable improvements in patient outcomes.”
The DURAMESH suture is already used in the EU and UK, having gained CE mark clearance in Q2 2021.