Back in January Benvenue Medical’s Kiva Vertebral Compression Fracture (VCF) Treatment System gained U.S. FDA clearance as we reported here. Now the George Washington University Hospital has become the first in the country to treat VCF patients with the system.
The Kiva System uses a small implant that is delivered 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.
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.
“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, MD, interventional neuroradiologist and Director of Interventional & Endovascular Neurosurgery at GW Hospital. “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, we’re proud to offer a new treatment approach with clear patient benefits for the large and growing population of VCF patients in the US 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.”
Source: Benvenue Medical, Inc.