VertiFlex enrolls patients in Superion IDE clinical trial

Oct 15 2010

VertiFlex, Inc., a leading innovator of minimally invasive and motion preserving spinal surgery technologies, today announced that 200 patients have been enrolled in its pivotal IDE clinical trial of the Superion® Interspinous Spacer (ISS).

“We are encouraged by our early patient results with Superion. This minimally invasive surgical option has the potential to benefit many patients we see in our clinic suffering from moderate spinal stenosis, which commonly afflicts those over the age of 45.”

The Superion IDE trial is a prospective, multi-center, controlled clinical trial studying the safety and efficacy of the Superion ISS compared to control arm X-STOP®, in patients with moderate lumbar spinal stenosis. The Superion ISS is a minimally invasive spinal implant, delivered fully percutaneously with nearly no disruption to the patients' muscle or other soft tissue. Further, it can be implanted on an outpatient basis under local anesthesia. There are over 1.2 million Americans diagnosed each year with lumbar spinal stenosis; a number expected to rise as the population ages. A significant portion of these patients are currently living with the limited pain relief received from existing non-surgical treatments, and are strong candidates for a minimally invasive, outpatient surgical option. The national trial is being conducted at 29 leading spine surgery sites throughout the US.

"We continue to be very pleased with the dedication of our community of clinical investigators," said Earl R. Fender, President & Chief Executive Officer of VertiFlex, Inc. "Enrollment is ahead of schedule and we are appreciative of all the support from our clinical teams across the country to bring this exciting minimally invasive technology to market. There are hundreds of thousands of patients who will benefit from Superion once this important trial is completed."

Peter Whang, MD, Associate Professor, Department of Orthopedics and Rehabilitation at Yale University School of Medicine stated, "We are encouraged by our early patient results with Superion. This minimally invasive surgical option has the potential to benefit many patients we see in our clinic suffering from moderate spinal stenosis, which commonly afflicts those over the age of 45."