SAN CLEMENTE, Calif.–(BUSINESS WIRE)–VertiFlex, Inc., a leading innovator of minimally invasive and motion preserving spinal surgery technologies, today announced that 100 patients have been enrolled in its pivotal IDE clinical trial of the Superion Interspinous Spacer (ISS).
The Superion IDE trial is a prospective, multi-center, controlled clinical trial studying the safety and efficacy of the Superion™ ISS compared to the X-STOP® in patients with moderate lumbar spinal stenosis. The national trial is being conducted at 23 leading spine surgery sites throughout the US and is expected to enroll approximately 330 patients.
“We are very excited about the enrollment momentum in this clinical trial,” said Earl R. Fender, President & Chief Executive Officer of VertiFlex, Inc. “We’ve put a lot of emphasis into building the support and infrastructure required to execute a clinical trial of this size, and I am very pleased with the results so far. I am grateful for the effort and support from our community of investigators who have committed themselves to completing this trial. Superion offers an advanced minimally invasive solution to patients suffering from lumbar spinal stenosis. Over 1,000 patients have already received treatment globally with Superion. We have a high confidence of success in our US IDE trial, since receiving compelling clinical evidence, from independent studies in Germany and Israel, treating a total of 192 patients.”
Spinal stenosis is a narrowing of the spinal canal that decreases space for the nerves as a person ages. It often leads to pain, weakness, and numbness in the legs, buttocks, back, and groin. There are over 1.2 million Americans diagnosed each year with lumbar spinal stenosis and it is the number one reason for surgery in patients over the age of sixty.
“The Superion Interspinous Spacer offers a unique solution for patients with moderate spinal stenosis,” commented Dr. Vito Loguidice from Warren Hospital in Phillipsburg, NJ, a Principal Investigator in the study. “This truly minimally invasive approach allows for immediate relief of pain, without the surgical morbidity associated with a traditional spinal operation, thus patients are likely to recover faster, and many leave the hospital within a few hours after the procedure.”
About VertiFlex, Inc.
VertiFlex is a privately held medical device company dedicated to the advancement of minimally invasive and motion preserving technologies for disorders of the spine. Founded in 2005 and headquartered in San Clemente, CA, VertiFlex currently markets products globally in addition to conducting a pivotal human IDE trial for a next generation interspinous spacer. The Superion Interspinous Spacer is a percutaneous titanium implant that fits between the spinous processes in the lumbar spine. Superion received CE mark in 2007. Current investors include Aberdare Ventures, Alta Partners, Morgenthaler, and New Enterprise Associates.
Superion™ is a trademark of VertiFlex, Inc.
X-STOP® is a registered trademark of Medtronic Spine LLC