Parallax Medical Inc has obtained FDA approval to proceed with the first randomized clinical trial of vertebroplasty products, and has enlisted top Interventional Radiologists and Surgeons in the field to begin patient selection before the end of this year. The trial will involve Parallax Medical's proprietary technology, including Secour Vx Vertebroplasty Cement with Tracers Imaging Particles.
"After many years of hard work, our team is thrilled to finally be able to provide the resources and coordinate the efforts between the physician community and the FDA so that we may begin this pivotal study," commented Howard Preissman, CEO of Parallax Medical Inc. "Vertebroplasty is an established procedure that has relieved pain for thousands of patients. The trial is a formal step that will provide further documentation that Parallax products are safe and effective."
The multi-center, single-masked, randomized study will evaluate the safety and efficacy of vertebroplasty products in treatment for pain associated with osteoporotic vertebral compression fractures, compared to a placebo treatment. The study design is the result of collaboration between Parallax and the FDA as part of the government agency's on-going effort to increase trial effectiveness and patient safety, and promote public interest. The physicians participating in the trial are among the leading specialists in the procedure, having practiced and published extensively in addition to training other physicians in the procedure. They are based at major medical facilities across the United States. Dr. Huy Do, of Stanford University Medical Center, has accepted the role of Principal Investigator for the trial.
"It is tremendously rewarding to see the kind of results we have with vertebroplasty," commented Dr. Mary E. Jensen, a pioneer of the procedure. "The outcome of the clinical trial will make it easier for more patients to be treated for their pain and benefit from dramatic improvements in quality of life."
Percutaneous vertebroplasty is a minimally invasive, typically outpatient procedure used to treat the pain associated with vertebral compression fractures caused by osteoporosis and metastatic tumors. During vertebroplasty, the collapsed vertebra is stabilized with specially formulated acrylic resin. For most patients, vertebroplasty provides immediate and lasting relief of pain related to the treated fracture. Many patients return to their normal activities within only a few days of having the procedure, and most report continued relief from pain months and years later.
First performed in France in 1984, percutaneous vertebroplasty was introduced in the United States in 1994 and has become widely available off label since 1997. Dozens of clinical papers in peer-reviewed journals have demonstrated the extraordinarily high success rates and low complication rates of vertebroplasty in treating the pain associated with osteoporotic vertebral compression fractures.