 |
| VertiFlex's Superion Interspinous Spacer System--Courtesy of VertiFlex |
VertiFlex gained a PMA approval for its Superion Interspinous Spacer System to treat spinal stenosis. The device is designed to be the least invasive, motion-preserving spinal spacer device. The startup has some high-profile venture capital backers but has made it through a pivotal trial and FDA approval largely on debt.
The news wasn't entirely unexpected given that a February FDA panel voted in support of Superion. The device is approved for patients with moderate lumbar spinal stenosis. Superion is implanted via a dime-sized cannula in a procedure that's typically performed under local anesthesia.
"As an early adopter of interspinous spacers, they have provided tremendous improvement for my patients suffering from lumbar stenosis," Dr. Nick Shamie, professor and chief of UCLA Orthopaedic Spine Surgery as well as co-medical director for VertiFlex, said in a statement. "As a next-generation technology, Superion offers the potential for even greater clinical benefit, with the least invasive indirect decompression possible, and the ability for patients to avoid traditional open spine surgery."
The pivotal trial was of 470 patients at 31 U.S. centers. It was a randomized trial in which half of the patients received Superion and the other half had Medtronic's ($MDT) X-Stop Spacer interspinous implant.
Superion met its primary clinical endpoint of a noninferior success rate compared to the X-Stop Spacer. At 24 months, it had a success rate of 52.7% compared to the X-Stop's 50.2%. Both devices offer an alternative to invasive spinal fusion surgery, which has recently fallen out of favor.
VertiFlex already sells the 510(k)-cleared Totalis Direct Decompression System to perform minimally invasive direct decompressions of the lumbar spine.
 |
| VertiFlex CEO Earl Fender |
It has raised about $35 million in debt and $8 million in equity, according to SEC filings. Venture investors include Aberdare Ventures, Alta Partners, New Enterprise Associates and Thomas, McNerney & Partners. All of these investors have a seat on the VertiFlex board.
"Superion has proven to be a safe, effective and least invasive solution for the treatment of spinal stenosis, in a mostly Medicare-aged population," commented VertiFlex President and CEO Earl Fender in a statement. He was a longtime executive at DePuy Spine, holding a series of positions culminating in worldwide president.
- here is the release