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Recent CommentsZyre Facet Implant System: A Breakthrough in the Treatment of Chronic Back Pain?
January 17, 2008
Spinal Elements announced that the first implantation of their highly-anticipated Zyre Facet Implant System in December 2007 was a success. It is the first arthroplasty system developed specifically to address facet joint pain.
Pioneer spine surgeon Rudolf Bertagnoli, M.D. performed the minimally-invasive, tissue-sparing procedure, which directly addresses the small facet joints present in every level of the spine.
“This procedure represents a breakthrough in the treatment of chronic back pain,” said Dr. Bertagnoli. “The technology provides a large population of patients living with chronic facet pain with an alternative to fusion or reliance on perpetual conservative treatments such as injections and manipulation.”
More than 50 percent of patients with chronic back pain exhibit some or most of that pain in the facet joints. A recently approved procedure called Total Disc Replacement (TDR) addresses degenerative disc disease (DDD), but fails to treat degenerative facet joints, which usually contribute to back pain in patients with DDD. Recent studies of patients who underwent TDR surgery indicate that over 50 percent of patients have progression of facet joint disease two years following the TDR procedure. Additionally, symptomatic facet joints are the leading contraindication for TDR present in 91 percent of patients requesting TDR but later undergoing other spinal procedures.
Currently, DePuy Spine, Inc., a unit of Johnson and Johnson, Synthes Inc., and Medtronic Sofamor Danek, Inc. have FDA-approved TDR products, but few companies have taken the next step into facet joint arthroplasty. Spinal Elements(TM) has distinguished itself by providing a procedure to augment the facet joints instead of removing them. Spinal Elements believes the market potential for its Zyre(TM) Facet Implant System may approach one billion dollars annually.
“We are very encouraged by this first procedure and believe there is a vast opportunity for the application of this technology,” commented Jason Blain, Chief Technology Officer for the Spinal Elements. “We believe the Zyre system will offer a host of patients surgical options in the future that simply are not available today.”
Source: Spinal Elements
CORTOSS: An Alternative to PMMA Bone Cement?
January 15, 2008
Orthovita, Inc., a spine and orthopedic biosurgery company, announced that it has submitted a 510(k) filing to the U.S. Food and Drug Administration for the use of its CORTOSS Bone Augmentation Material in vertebral augmentation.
This filing is based on data collected in three U.S. clinical investigations conducted under FDA Investigational Device Exemptions (IDEs) and several European studies, and is intended to demonstrate that the performance of CORTOSS is substantially equivalent to polymethylmethacrylate (PMMA) bone cement. The extensive clinical study of CORTOSS demonstrates that the same degree of clinical improvement in pain and function is achieved with approximately 40% less material than PMMA when augmenting the vertebral body. CORTOSS also provides other benefits, including consistent handling characteristics and viscosity.
The CORTOSS 510(k) filing includes data on 469 vertebral compression fracture patients treated with CORTOSS and 94 patients treated with PMMA with follow up ranging from 11 months to over 3 years. This data includes results from Orthovita’s pivotal, prospective, randomized clinical study conducted under an FDA IDE. In the pivotal study, a total of 162 patients were treated with CORTOSS and 94 patients were treated with PMMA. Two-year follow up for all 256 of the pivotal study patients will be completed in February 2009.
“The 510(k) filing is a key step toward the introduction of CORTOSS to the U.S. market as an alternative to PMMA bone cement for the treatment of vertebral compression fractures. To the Company’s knowledge, the CORTOSS 510(k) filing contains the largest prospective, randomized, controlled clinical dataset ever assembled in the treatment of vertebral compression fractures. We would like to express our gratitude to all our investigators and their personnel for their hard work and invaluable contributions that helped us achieve this milestone,” said Antony Koblish, President and Chief Executive Officer of Orthovita.
Source: Orthovita, Inc.