VertiFlex, a provider of minimally invasive and motion preserving spinal surgery technologies, has reported that 200 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 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 and it can be implanted on an outpatient basis under local anesthesia, VertiFlex said.
VertiFlex president and chief executive officer Earl Fender said they continue to be very pleased with the dedication of their community of clinical investigators and enrollment is ahead of schedule and they are appreciative of all the support from their clinical teams across the country to bring this exciting minimally invasive technology to market.