VertiFlex said that the Superion ISS allows the procedure to be performed on an outpatient basis under local anesthesia. It had received CE mark in 2007.
VertiFlex added that the device is being implanted for the treatment of spinal stenosis in a prospective, multi-center, controlled clinical trial by not only traditional spine surgeons, but also interventionalists such as pain doctors, who will greatly expand the potential reach of the therapy.
Reportedly, 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 60.
Earl Fender, president and chief executive officer of VertiFlex, said: “I am very pleased that enrollment continues to track at an accelerated rate and ahead of plan. Based on our approved statistical plan, we believe enrollment will complete with approximately 250 randomised patients sometime in early 2011.
“We also have encouraging early indicators that our results are trending toward endpoint success. I am grateful for the strong commitment and collaboration from our community of clinical investigators to help bring this unique technology to market.”
VertiFlex currently markets products globally in addition to conducting a pivotal human IDE trial for a next generation interspinous spacer.
