Integra LifeSciences Receives FDA Clearance for Titan(TM) Reverse Shoulder System
PLAINSBORO, N.J., July 31, 2013 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that the Integra® Titan™ Reverse Shoulder System has received 510k clearance from the U.S. Food and Drug Administration (FDA). Integra expects to begin a limited market release in the United States in the third quarter of 2013, and upon CE Mark clearance in Europe, begin a full global commercial launch.
The Reverse Shoulder System is built on a unique platform stem. This platform stem 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 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. This flexibility provides surgeons with minimally invasive intraoperative options, and the ability to offer continued care for the lifetime of the patient.
William Geissler, M.D., Professor of Orthopaedic Surgery, University of Mississippi Medical Center, said that, "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. 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, Integra's President, Extremity Reconstruction. "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."
The global shoulder replacement market is estimated to reach approximately $865 million in 2014 and $1.3 billion by 2017. With the addition of the Titan Reverse Shoulder System, which addresses both the press-fit and cemented reverse shoulder market, Integra is well positioned to gain a key foothold in this rapidly growing market.
Integra will offer surgeons hands-on training on the Titan Reverse Shoulder System at the "Clinical Concepts in Shoulder Arthroplasty Course" being held at the Pacific American Life Science Learning Center on August 10, 2013 in San Diego, CA.
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, spine surgery, and reconstructive and general surgery. For more information, please visit www.integralife.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning the products and services provided by Integra. Such forward looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of surgical professionals to use Integra products may affect the prospects for their use in surgical procedures. In addition, the economic, competitive, governmental, technological and other factors, identified under the heading "Risk Factors" included in Item IA of Integra's Annual Report on Form 10-K for the year ended December 31, 2012 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.
CONTACT: United States,
Integra LifeSciences Holdings Corporation
Gianna Sabella
Director, Corporate Communications
Phone: (609) 936-2389,
Email: gianna.sabella@integralife.com