VertiFlex wraps up enrolment in pivotal IDE clinical study of Superion ISS.
M2 PHARMA-December 14, 2011-VertiFlex wraps up enrolment in pivotal IDE clinical study of Superion ISS(C)2011 M2 COMMUNICATIONS
14 December 2011 - Medical device firm VertiFlex Inc said on Tuesday it had completed the enrolment in its pivotal IDE clinical study of the Superion Interspinous Spacer (ISS).
The trial data will serve as a basis for the company to seek a premarket approval (PMA) from the US Food and Drug Administration (FDA).
IDE is a prospective, multi-centre, controlled clinical trial examining the safety and efficacy of the Superion ISS compared to control arm X-STOP IPD in healthy adults suffering from at least six months of moderate lumbar spinal stenosis who have shown no response to conservative therapy.
The study is performed at 31 leading spine surgery sites in the US. The trial endpoint is the rate of overall success at 24 months.
The Superion ISS received CE mark in 2007. The minimally invasive interspinous spacer is inserted via a single, half-inch skin incision and once in place acts as a support column to open the passageways that contain the spinal cord and nerve roots. The Superion ISS has been implanted in more than 2,000 patients around the world.
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|Date:||Dec 14, 2011|
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