The George Washington University Hospital and Benvenue Medical, Inc., announced that it is the first in the U.S. to treat vertebral compressions fracture (VCF) patients with the Kiva VCF Treatment System following its clearance by the U.S. Food and Drug Administration 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.
VCFs occur when a vertebra (bone in the spine) cracks, fractures or collapses. They are a serious condition that frequently goes undiagnosed.VCFs are most often caused by osteoporosis, and the National Osteoporosis Foundation estimates that there are 700,000 osteoporosis-related vertebral compression fractures annually in the U.S. alone; however, only 200,000 in the U.S and around the world are treated with the “gold standard” of care, which is a procedure called balloon kyphoplasty. Other causes of VCFs include trauma and malignant bone tumors that cause the spine to collapse.
“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.
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 balloonkyphoplasty – 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 VCFpatients 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.”
About the Kiva VCF Treatment System
The Kiva VCF Treatment System provides a new approach to the treatment of painful VCFs. The Kiva System features a proprietary flexible implant made from PEEK-OPTIMA®, a biocompatible polymer that is widely used and well accepted as a spinal implant. The Kiva implant is designed to provide structural support to the vertebral body and a reservoir to direct and contain bone cement. The implant is deliveredpercutaneously over a removable guidewire in a continuous loop into the vertebral body through a small diameter, single incision. The amount of the Kiva implant delivered can be physician-customized during the procedure to adjust to various fracture types. The Kiva System received 510(k) clearance from the U.S. Food and Drug Administration in January 2014 for use in the reduction and treatment of spinal fractures in the thoracic and/or lumbar spine from T6-L5. It is intended to be used in combination with the Benvenue Vertebral Augmentation Cement Kit. TheKiva System is also available in Europe and is distributed by Zimmer Spine.
About Benvenue Medical, Inc.