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November 5, 2009
By: Michael Barbella
Managing Editor
The MagniFuse PC (posterior cervical) bone graft from Osteotech Inc. recently has been used for the first time in a spinal surgery in the United States. The device is a new tissue-based product that builds on the company’s proprietary MagniFuse bone graft technology platform.
Dr. Orin Atlas, an orthopedic spine surgeon and chief of spine surgery at Virtua-Burlington Medical Center in Mt. Holly, N.J., used the device for the first time to perform a posterior cervical fusion.Posterior cervical fusion is a surgical procedure to stop motion between two or more vertebrae that may be causing neck pain or damage to the nerves that extend into the upper extremities.By the kickoff of NASS, the company reported approximately 25 surgeries with the new device.
“In using MagniFuse for the first time, I found the product to be unique from a biologic perspective and easy to work with from a surgical placement perspective,” Atlas said.“MagniFuse required minimal hydration and the self-contained delivery system made it easily conformable to a unique delivery system and is unlike any other product on the market.”
Surgeon feedback was key to product development, Osteotech officials said.
“As we have continued to develop MagniFuse, we have incorporated feedback from surgeons that has allowed us to hone the procedure-specific characteristics and clinical utility of the initial new products we are bringing to the spine market,” said Sam Owusu-Akyaw, Osteotech’s president and CEO. “We believe our MagniFuse products will solve many of the implantation challenges that are inherent to both particle- and viscous-based bone graft products such as existing growth factor, stem cell and premium synthetic products. Additionally, based upon its ease-of-use, unique delivery and containment characteristics, MagniFuse products may enable surgeons to advance their grafting techniques.”
MagniFuse, which has received clearance from the U.S. Food and Drug
Administration, is Osteotech’s new, patented bone graft technology platform
that supports a family of products used when injury or disease creates a need for bone fusion or new bone growth.
MagniFuse is delivered in a unique, resorbable self-contained delivery system. It provides a scaffold that creates a highly exposed surface area comprising 100 percent bone material that is shaped and oriented to provide guided bone healing and that may encourage stronger and more rapid mature bone formation.
The company said the delivery system also allows for targeted bone formation because it reduces graft site migration once implanted. MagniFuse also is visible in radiographs, thus providing evidence of its proper placement post-surgery.
These characteristics and others solve many of the challenges associated with currently marketed products including stem cells, growth factors and premium synthetics, officials said.
Owusu-Akyaw said he was eager to begin the first phase of the company’s strategic launch of MagniFuse, during which data will be collected on the human clinical experiences that company officials expect will further validate their scientific approach and therapeutic efficacy.
“Based upon early feedback, we believe the usage curve will continue to increase as we move toward phase two of our launch in 2010,” he added.
Osteotech, Inc., is headquartered in Eatontown, N.J.
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