Anulex Technologies Receives FDA 510(k) Clearance for the Inclose Surgical Mesh System
Aug 22, 2005 - Anulex Technologies, Inc. announced today that it has received FDA 510(k) clearance of its Inclose Surgical Mesh System.
The Inclose Surgical Mesh System is a novel, patented implant that is designed to provide a barrier and scaffold to facilitate the repair of soft tissue. The surgical mesh implant is comprised of polyethylene terephthalate (PET) monofilament braid material that is preloaded on a disposable delivery tool. The mesh implant loaded on its delivery tool has a low profile allowing it to be inserted in a minimally invasive manner prior to being expanded below the aperture of a tissue defect. The mesh implant can be secured in place with anchors comprised of nonabsorbable surgical suture.
Commenting on the approval, Mike McCormick, CEO of Anulex Technologies, Inc. said, "Receiving FDA 510(k) clearance is a significant corporate milestone for Anulex. We are pleased to receive U.S. regulatory clearance of our surgical mesh that is designed to provide a fast, simple, and safe way for surgeons to repair soft tissue."
McCormick indicated that the company plans to conduct additional studies of the Inclose Surgical Mesh System as commercial initiatives and support programs continue to evolve.
About Anulex
Anulex Technologies, Inc. is a privately held company focused on developing medical technology to repair soft tissue with primary interests in the soft tissues of the spine.
Company Contact:
Doug Schoenberg
Anulex Technologies, Inc.
952-224-4000
Dschoenberg@anulex.com