The FDA ortho panel meeting to consider VertiFlex Inc.’s premarket approval (PMA) application for the Superion interspinous spacer system has been moved to February 20, 2015.
FDA Postpones VertiFlex Ortho Panel Until February 2015
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Secondary
Apparently the dog ate the FDA’s homework as, according to a December 12, 2014 VertiFlex press release, the meeting was moved by the FDA because they were unable to complete their internal review of the PMA data in time for the December meeting.
While clearly an FDA screw up, Earl Fender, VertiFlex’s president and CEO, said he was still “excited to be in the final stages of our Superion PMA application and look forward to the February 20 Panel date. While disappointed in the postponement of the December panel, the agency has advised VertiFlex that it remains committed to meeting its MDUFA [Medical Device User Fee and Modernization Act] final decision timeline goal, and will continue collaborative efforts with the company to resolve all issues leading to the final decision. That position is but one example of the positive working relationship we’ve had with the FDA throughout this PMA process. While we believe we were fully prepared for panel on December 12, we will use the additional time for further analysis and preparation, and we continue to anticipate a positive outcome with the trial.”
Compared to X-STOP
Fender had previously said the panel is going to see evidence from the “largest and most rigorous FDA trial ever completed for spinal stenosis.” The device is for the treatment of patients with lumbar spinal stenosis. The IDE (investigational device exemption) trial involved enrollments of 470 patients between June 2008 and December 2012 at 31 centers across the U.S. Patients were randomized 1:1 to either the Superion ISS or the commercially available X-STOP IPD.
The company submitted its final module of the PMA this past April. The final module covers the clinical results from the Superion IDE trial evaluating the device’s safety and effectiveness.
Proposed Indications
The proposed “Indication for Use” for the device, as stated in the PMA, is as follows:
“Treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate lumbar spinal stenosis, with or without Grade 1 spondylolisthesis, confirmed by X-ray, MRI and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing.”
“Patients with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, numbness, and/or cramping, with or without back pain. The Superion ISS may be implanted at one or two adjacent lumbar (L) levels in patients in whom treatment is indicated at no more than two levels, from L1 to L5.”
No details about the logistics of the upcoming panel meeting were provided.
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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