The George Washington University Hospital, along with Benvenue Medical, Inc., has announced that it is the first in the U.S. to treat vertebral compression fracture (VCF) patients with the Kiva VCF Treatment System following its clearance by the FDA in January. The minimally invasive Kiva System, which demonstrated important patient benefits in a large, international, FDA-approved clinical trial, is the first new approach to the treatment of VCFs in more than a decade.
GWU Hospital First to Treat VCF With Kiva
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“My patients with VCFs are in significant and debilitating pain, and with the Kiva System, I am able to significantly reduce their pain and restore function while attempting to restore their natural spine anatomy, ” said Wayne Olan, M.D., interventional neuroradiologist and Director of Interventional & Endovascular Neurosurgery at GW Hospital, in the February 18, 2014 news release. “Our use of the Kiva VCF Treatment System further demonstrates our commitment at GW Hospital to providing our patients with access to the most advanced treatments available today that are proven under the highest scientific standards.” Dr. Olan has treated two patients in the last week with the Kiva System.
With the Kiva System, surgeons can deliver a small implant through a single, small-diameter incision. The cylindrical implant is designed to provide structural support to the vertebral body and a reservoir to direct and contain the bone cement that is used to repair VCFs. The traditional approaches rely solely on a bolus of bone cement. In clinical trials, the Kiva System was shown to meet or exceed the performance of balloon kyphoplasty—the current standard of care for the treatment of VCFs—in every outcome evaluated.
“With the Kiva System, we’re proud to offer a new treatment approach with clear patient benefits for the large and growing population of VCF patients in the U.S. market, ” said Robert Weigle, CEO of Benvenue Medical, Inc. “GW Hospital’s early adoption of the Kiva System demonstrates that spine specialists are looking for evidenced-based devices that offer benefits beyond what current therapies are able to provide.”
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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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