ALPHATEC SPINE INITIATES OSSEOFIX CLINICAL STUDY.
"The patient was suffering from an acute osteoporotic T-12 compression fracture. The OsseoFix system was easy to use. The surgery went smoothly and I was able to regain considerable vertebral height and restabilize the vertebra in the patient. Following the surgery, the patient has minimal pain and has not required external support or bracing," said Dr. Bertagnoli.
Dr. Bertagnoli is the lead investigator in a 30-patient study of the OsseoFix that is being conducted by Alphatec in Germany. Following each OsseoFix procedure, each patient will be evaluated at appropriate post-operative time intervals to determine their level of pain relief and vertebral stability. After the completion of the study, the study results will be submitted for publication in a peer-reviewed spine surgery journal.
"The first OsseoFix surgery is another milestone that reflects Alphatec's dedication to improving the quality of life of older patients and treating the aging spine," said Dirk Kuyper, Alphatec's president and CEO. "Once cleared by the FDA, the OsseoFix Spinal Fracture Reduction System will be a valuable addition to Alphatec's product portfolio. We are pleased to offer spine surgeons increased options for treating patients with debilitating spine deformities, such as vertebral compression fractures. We expect OsseoFix to receive FDA clearance and be launched in the U.S. by late 2008."
Alphatec submitted pre-market notification to the FDA for a 510(k) clearance for OsseoFix in June 2008.
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 OsseoFix 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.
About Alphatec Spine
Alphatec Spine, Inc. is a wholly owned subsidiary of Alphatec Holdings, Inc. (Nasdaq:ATEC). Alphatec Spine is a medical device company involved in the design, development, manufacturing and marketing of products for the surgical treatment of spine disorders, primarily focused on treating conditions related to the aging spine. The company's mission is to combine world-class customer service with innovative, surgeon-driven design that will help improve the aging patient's quality of life. The company is poised to achieve its goal through new solutions for patients with osteoporosis and other aging spine deformities, improved minimally invasive products and techniques and integrated biologics solutions. In addition to its U.S. operations, Alphatec Spine also markets its spine products in Europe. In Asia, the company markets a broad line of spine and orthopedic products through its subsidiary, Alphatec Pacific, Inc.
For more information, visit http://www.alphatecspine.com or call 760/494-6749.
|Printer friendly Cite/link Email Feedback|
|Publication:||Biotech Equipment Update|
|Date:||Sep 1, 2008|
|Previous Article:||FDA APPROVES PROMUS EVEROLIMUS-ELUTING CORONARY STENT.|
|Next Article:||ST. LUKE'S EPISCOPAL HOSPITAL TO ADD CYBERKNIFE SYSTEM.|
|Alphatec reports record sales, net loss.|
|Clinical neuroimaging; cases and key points.|
|DAYNAMO SEMI RIDGID ROD SYSTEM LICENSE TERMINATED.|