DePuy OrthoTech releases Restore® Orthobiologic Implant for soft tissue treatment

Tracy, CA--DePuy OrthoTech proudly announces availability of the Restore® Orthobiologic Soft Tissue Implant, which was recently cleared for commercial distribution via an U.S. FDA Section 510(k) Pre-market Notification. The Restore Orthobiologic Soft Tissue Implant, a ten layer laminated device, is intended to support weak soft tissues.

"We’ve investigated the Restore Orthobiologic Implant in pre-clinical animal studies in rotator cuff, Achilles tendon, patellar tendon and tensor fascia lata repairs. The results showed healing with normal looking musculoskeletal tissues," said Dick Tarr, Senior Vice President of Research and Orthobiologics, DePuy, a Johnson & Johnson Company.

This product is one of the first of its kind to be introduced in the worldwide orthopaedic market. It is expected to revolutionize the treatment of soft tissue tears and damage. Traditionally, the treatment for reinforcing lost or damaged tissue has been to use auto- or allograft tissues. The Restore Orthobiologic Implant gives the surgeon a less invasive, alternative treatment.

"Patients and surgeons will no longer have to agonize over the choice of what materials to use for reinforcing soft tissues in their reconstructive surgeries. Having an off-the-shelf, biologically-based substitute to offer patients has a theoretical advantage that cannot be denied," said Leslie S. Matthews, MD, Chief of Orthopaedic Surgery, Union Memorial Hospital, Baltimore, MD.

"What’s most amazing about the product is how it’s absorbed and incorporated into the body and replaced by the host tissue. It’s quite amazing how adaptable it is. That opens up a world of possibilities," said Kirk L. Jensen, MD, Assistant Clinical Professor, Orinda, California.

Restore Orthobiologic Soft Tissue Implant is composed of a material called SIS, which stands for small intestine submucosa. The SIS is derived from porcine small intestines. Once these layers of intestine are removed, they are disinfected and processed into different forms, sterilized and stored for future use. Manufacturing of the product occurs at DePuy’s Warsaw, IN facility.

The material was developed through a partnership between Purdue University and DePuy Orthopaedics, Inc. of Warsaw, IN. DePuy holds exclusive rights to all orthopaedic applications of SIS. DePuy OrthoTech plans to offer a complete line of Restore orthobiologic products, which are in development and clinical testing phases.

The Restore Orthobiologic Implant is marketed and distributed through DePuy OrthoTech, a subsidiary of DePuy, Inc., a Johnson & Johnson Company.

Based in Tracy, CA, DePuy OrthoTech also manufactures and distributes arthroscopy/sports medicine products, patient care products, orthopaedic braces and cold therapy products.

DePuy, a Johnson & Johnson Company, is the world’s oldest and largest orthopaedic company and is a leading designer, manufacturer and distributor of orthopaedic devices and supplies. Its products are used primarily by orthopaedic medical specialists and, in the case of the company’s spinal implants, spinal and neurosurgeons. DePuy products are used in both surgical and nonsurgical therapies to treat patients with musculoskeletal conditions resulting from degenerative diseases, deformities, trauma and sports-related injuries.

For more information about DePuy OrthoTech’s Restore Orthobiologic Soft Tissue Implant, contact Chris Butler, Product Manager, DePuy OrthoTech at (800) 227-1554.

Tammy Y. Allen
Marketing Communications
Telephone: (219) 372-7355
Fax: (219) 372-7151