Healthcare Industry News: Spacer System
News Release - September 5, 2008
Orthofix International Announces Expansion of Product Offerings
510(k) approval received for new PILLAR(TM) SA spine interbody deviceNotification of Approval for CentroNail internal fixation device received in Japan
BOSTON--(HSMN NewsFeed)--Orthofix International N.V. (NASDAQ: OFIX ) (the Company) announced today that the Company has received 510(k) approval from the FDA for its unique new PILLAR SA spine interbody device, and also received a Notification of Approval to begin selling its CentroNail family of nailing systems in Japan.
PILAR SA is the latest addition to Orthofix’s line of PILLAR PEEK Spacer Systems. The new spinal device is designed to be used in most cases as a stand-alone implant between the spinal vertebrae or as a partial vertebral body replacement, without the need for supplemental internal fixation, during lumbar spinal fusion procedures. Potential benefits of eliminating the need for supplemental fixation include less trauma for the patient, and cost savings for hospitals resulting from reduced surgery times. PILLAR SA also includes a unique cover plate designed to prevent the screws from backing out. The Company expects PILLAR SA to be available in the U.S. in 2009. The interbody device markets in the U.S. and Europe together were estimated to be over $1 billion in 2007.
Orthofix’s family of CentroNail Nailing Systems is designed to stabilize bone fractures in the leg. The internal fixation devices feature titanium construction with multiple locking options, reliable mechanical distal targeting and specialized instrumentation. First launched in January of 2006, the CentroNail line includes both tibial and femoral intramedullary nails.
“These two approvals are very important to our respective spine and orthopedic businesses, both in the U.S. and Japan,” said Orthofix’s CEO Alan Milinazzo. “The continuous introduction of innovative new products to the market, and expansion of the global distribution of our broad product portfolios are key aspects of our growth strategy.”
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.
Source: Orthofix International
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