Over 100 Patients in Europe Treated with the OsseoFix Spinal Fracture Reduction System for Vertebral Compression Fractures. Over 40 Surgeons Trained in Europe with Next Training Session Oversubscribed.
Alphatec Holdings, Inc., the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, today announced that, as of June 1, 2009, over 115 patients in eight European countries have been treated with the OsseoFix™ Spinal Fracture Reduction System, the Company’s innovative product for the treatment of vertebral compression fractures. The first European training session was held at the University of Vienna in mid-December 2008. The first shipments of OsseoFix products into Europe occurred at the end of December 2008.
“We are pleased with the significant surgeon adoption of OsseoFix across Europe. Surgeons who are using the OsseoFix system benefit from the potential to improve patient outcomes by providing an enhanced ability for vertebral height maintenance while using less cement as a result of the permanent titanium implant. As this product represents our initial launch into the aging spine market, we are particularly pleased with the manner in which the adoption of OsseoFix appears to be accelerating. Over 60 patients were treated in May alone,” said Dirk Kuyper, Alphatec Spine’s President and Chief Executive Officer. Mr. Kuyper added, “Our next training lab, which will be held in July in Vienna, is oversubscribed, with 50 surgeons and over 70 total participants already enrolled in what will be our third training session.”
The OsseoFix system is not yet approved for sale in the United States and is currently under 510(K) review with the U.S. Food and Drug Administration.
About Vertebral Compression Fractures and the OsseoFix Spinal Fracture Reduction System
According to the National Osteoporosis Foundation there were 700,000 osteoporotic vertebral compression fractures in the U.S., of which only one-third are estimated to be diagnosed. Common causes of vertebral compression fractures include osteoporosis, trauma, or a pre-existing disease at the fracture site.
Currently, the two most common procedures used to treat vertebral compression fractures are kyphoplasty and vertebroplasty. A kyphoplasty procedure involves injecting a balloon through a catheter into the damaged vertebra, inflating the balloon to restore height, and reinforcing the resultant space made by the balloon with bone cement. A vertebroplasty procedure involves injecting bone cement directly into the compressed vertebral body under high pressure, with the goal of stabilizing the fracture.
Alphatec Spine designed and developed the OsseoFix system to expand the market for surgical solutions for vertebral compression fractures with what it believes to be an improvement over the most common procedures being used today. OsseoFix is designed to allow for improved fracture reduction and designed to use less cement during a surgical procedure, both of which Alphatec believes reduces the risk of cement extravasation, reduces surgical complications and increases clinical efficacy.
Source: Alphatec Spine