Healthcare Industry News: Fixation System
News Release - October 2, 2008
Orthofix International Receives 510(k) Approval For Next Generation Lumbar Fixation System
BOSTON--(HSMN NewsFeed)--Orthofix International N.V. (NASDAQ: OFIX ) (the Company), announced today it has received 510(k) approval from the FDA for its next generation Firebird™ Spinal Fixation System.Firebird is a comprehensive system with a modular screw designed to provide surgeons with intra-operative flexibility during various thoracolumbar spine procedures, including the treatment of degenerative disc disease and deformity corrections. The Firebird system can also be used during a minimally invasive surgical approach in conjunction with instrumentation available in the Company’s ProView Minimal Access Portal System. The Company expects to make the Firebird system widely available in the U.S. beginning during the first quarter of 2009.
“The Firebird system is an important addition to our expanding spine product portfolio, giving us new capabilities to assist surgeons in the treatment of deformity corrections,” stated Alan Milinazzo, Orthofix’s President and Chief Executive Officer. “This represents the eighth 510(k) approval Orthofix has received from the FDA this year, and demonstrates the product pipeline remains robust within our spine division.”
The company has outlined a growth strategy for its spinal implant business that is built upon steady product launches as well as enhanced distribution in both the United States and certain key international markets. Firebird represents the third product approval from the FDA for the spine division in the past 60 days.
Brad Mason, Orthofix Group President of North America commented, “The Firebird system is a highly differentiated thoracolumbar system which allows us to address a number of anatomical spinal issues. This is one of the key product launches we are anticipating, and should provide a positive impact on our U.S. spine business by generating increased interest in our product portfolio going into the North American Spine Society meeting in Toronto later this month.”
About Orthofix
Orthofix International, N.V., a global medical device company, offers a broad line of minimally invasive surgical, and non-surgical, products for the spine, orthopedic, and sports medicine market sectors that address the lifelong bone-and-joint health needs of patients of all ages–helping them achieve a more active and mobile lifestyle. Orthofix’s products are widely distributed around the world to orthopedic surgeons and patients via Orthofix’s sales representatives and its subsidiaries, including BREG, Inc. and Blackstone Medical, Inc., and via partnerships with other leading orthopedic product companies. In addition, Orthofix is collaborating in R&D partnerships with leading medical institutions such as the Orthopedic Research and Education Foundation, Rutgers University, the Cleveland Clinic Foundation, Texas Scottish Rite Hospital for Children and National Osteoporosis Institute. For more information about Orthofix, please visit www.orthofix.com.
Forward-Looking Statements
This communication contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which may include, but are not limited to, statements concerning the new product introductions, financial projections, financial condition, results of operations and businesses of Orthofix and its subsidiaries and are based on management’s current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements.
Factors that could cause or contribute to such differences may include, but are not limited to, risks relating to the expected sales of its products, including recently launched products, unanticipated expenditures, changing relationships with customers, suppliers and strategic partners, risks relating to the protection of intellectual property, changes to the reimbursement policies of third parties, changes to and interpretation of governmental regulation of medical devices, the impact of competitive products, changes to the competitive environment, the acceptance of new products in the market, conditions of the orthopedic industry and the economy, corporate development and market development activities, including acquisitions or divestitures, unexpected costs or operating unit performance related to recent acquisitions and other factors described in our annual report on Form 10-K and other periodic reports filed by the Company with the Securities and Exchange Commission.
Source: Orthofix
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