New bio-implant cleared for general and plastic surgery applications

Tutogen Medical Inc. (Clifton, NJ) has received FDA 510(k) clearance to market its Tutopatch bio-implant product for the indications of general and plastic surgery.

Specific indications include vaginal and rectal prolapse, pelvic floor reconstruction and hernias (including inguinal and umbilical).

Tutopatch is the first Xenograft tissue that will be offered by Tutogen in the United States. This introduction follows the successful launch of Tutopatch in Europe.

The product is produced from bovine pericardium harvested from the company's controlled bovine herd and is preserved using Tutogen's patented Tutoplast process, which virally inactivates and preserves the tissue.

Manfred Kruger, president and CEO of Tutogen, said: "Tutopatch will allow Tutogen to rapidly expand its market share by eliminating dependence on human tissue. This is another step in our drive to become a leader in the bio-implant industry."

Tutogen manufactures bio-implants for neurosurgical, orthopedic, reconstructive and general surgical indications. The company's Tutoplast products are sold and distributed worldwide by the Mentor Corp., Sulzer Medica, IOP Inc. and through subsidiaries in the U.S. and Germany.

Edited by Ursula Jones
Managing Editor, Medical Design Online