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Company received FDA clearance this summer.
September 23, 2013
By: Michael Barbella
Managing Editor
Integra LifeSciences Corp. reported the first implantation of its Integra Titan Reverse Shoulder System in the United States. The system, which is used for shoulder replacement surgery, was implanted by William Geissler, M.D., professor of orthopedic surgery at the University of Mississippi Medical Center. The company received U.S. Food and Drug Administration clearance for the Titan device at the end of July. “I was very pleased with the flexibility of the system’s platform stem,” said Geissler. “The patient had two unsuccessful attempts at massive cuff repair and was in severe pain, with limited range of motion. During surgery, we found that the patient’s cuff tear was not repairable, which, combined with such severe arthritis, made her the perfect patient for reverse shoulder arthroplasty. “The instrumentation really helped in placement and orientation of the prosthesis, and the shoulder was very stable intra-operatively,” he added. “The featured modularity of the system helped me custom fit the prosthesis to the patient, and the press-fit application simplified the procedure and saved precious operative time.” According to the company, the system is built on a unique platform stem that simplifies the conversion of a primary total shoulder, or hemi for fracture, to a reverse shoulder, without the need to remove a stem that is well-fixed in the patient’s bone. The system provides interchangeable components, which allow all primary, reverse, and fracture humeral bodies to be used with either the press-fit or cemented platform stems. This flexibility, company officials claim, provides surgeons with minimally invasive intraoperative options, and the ability to offer continued care for the lifetime of the patient. “The first implantation of our new Reverse Shoulder System is a great accomplishment, and we are very pleased with the outcome,” said Robert Paltridge, president of Extremity Reconstruction for Integra. “The system greatly expands our shoulder portfolio and offers surgeons additional options for patients who have exhausted other treatments. We look forward to the continued success and growth in this market.” The company estimates the global shoulder replacement market will reach approximately $865 million in 2014 and $1.3 billion by 2017. Plainsboro, N.J.-based Integra LifeSciences makes devices for orthopedic extremity surgery, neurosurgery, spine surgery, as well as reconstructive and general surgery.
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