San Clemente, Calif.-based VertiFlex, a manufacturer of minimally invasive and motion-preserving spinal surgery technologies, has announced that 100 patients have been enrolled in its IDE clinical trial of the Superion Interspinous Spacer, according to a VertiFlex news release.
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.
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. The Superion ISS provides a minimally invasive approach to relieve pain without the surgical morbidity associated with a traditional spinal operation, according to the report.
"We are very excited about the enrollment momentum in this clinical trial," Earl R. Fender, president & CEO of VertiFlex, said in the release. "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."
Read the VertiFlex release on the Superion ISS IDE trial.
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.
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. The Superion ISS provides a minimally invasive approach to relieve pain without the surgical morbidity associated with a traditional spinal operation, according to the report.
"We are very excited about the enrollment momentum in this clinical trial," Earl R. Fender, president & CEO of VertiFlex, said in the release. "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."
Read the VertiFlex release on the Superion ISS IDE trial.