Tuesday, April 10, 2007
FDA Approves C-QURLite Mesh for Hernia Repair
Filed under: Surgery
Having a hernia is never fun, but fixing it sure is! Hernias are repaired more than 700,000 times a year. The procedure usually involves the suturing of a mesh, which prevents the loops of the small bowel escaping out of the abdomen.
The FDA gave 510(K) approval for a new mesh product from Atrium Medical. The device's claim to fame is its unique non-polymeric Omega 3 fatty acid bioabsorbable gel coating. The coating supposedly heals more "gently" than the more commonly used polymeric coating, and leaves behind a more natural collagenous matrix with a lower risk of adhesions. The device is also coated in a bioabsorbable oil that lubes it up and eases placement inside the body.
Atria's claims are from "pre-clinical" studies, so it could be too soon to judge the device's effectiveness. In addition, "Light" meshes have been shown to have a higher rate of hernia recurrence, although they demonstrated lower rates of foreign body responses.
Read the press release here...
Product page...
(0)
examples: <b>Bold</b> <i>Italic</i>
