Integra Reverse Shoulder System Gains FDA Clearance
Plainsboro, N.J.-based Integra LifeSciences Holdings Corporation has received 510(k) clearance from the U.S. Food and Drug Administration for its Titan reverse shoulder system. Reverse shoulder replacements are usually performed on patients with large rotator cuff tears who have developed a complex type of shoulder arthritis called cuff tear arthropathy. Integra intends to begin a limited U.S. market release in the third quarter of 2013, and upon CE mark approval in Europe, begin a full global commercial launch.
The reverse shoulder system is touted to simplify the conversion of either a total or partial shoulder to a reverse shoulder without the need to remove a stem that is well-fixed in the patient’s bone. The system offers fully interchangeable components, which allow all primary, reverse, and fracture humeral bodies to be used with either the press-fit or cemented platform stems. These features are hoped to provide minimally invasive intraoperative options and surgeons the ability to offer continued care for the lifetime of the patient.
“The versatility of the Integra Titan reverse shoulder system will allow me to custom fit the prosthesis intraoperatively to the unique anatomy of each of my patients,” said William Geissler, M.D., professor of orthopedic surgery at the University of Mississippi Medical Center. “Additionally, it builds off the same platform-based press-fit stem as the Titan total shoulder, which allows for easier conversion, if ever required.”
“The reverse shoulder system is an exciting addition to Integra’s shoulder portfolio, which includes the total shoulder system and the humeral resurfacing arthroplasty system,” said Robert Paltridge, president of Integra’s extremity reconstruction business. “The patient and surgeon benefits built into our new platform-based system are a true testimony to our continued investment in advancing cost-effective technology in shoulder surgery.”
Integra makes medical technology for orthopedic extremity surgery, neurosurgery, spine surgery, and reconstructive and general surgery.