Aug 3 2010
VertiFlex, Inc., a leading innovator of minimally invasive and motion preserving spinal surgery technologies, today announced that 150 patients have been enrolled in its pivotal IDE clinical trial of the Superion Interspinous Spacer (ISS).
“I am very pleased that enrollment continues to track at an accelerated rate and ahead of plan”
The Superion ISS is a generationally advanced spinal implant delivered through a unique and proprietary percutaneous technique that allows the procedure to be performed on an outpatient basis under local anesthesia. 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.
"I am very pleased that enrollment continues to track at an accelerated rate and ahead of plan," said Earl R. Fender, President & Chief Executive Officer of VertiFlex, Inc. "Based on our approved statistical plan, we believe enrollment will complete with approximately 250 randomized 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."
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.
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