|By PR Newswire||
|February 25, 2014 08:05 AM EST|
SANTA CLARA, Calif., Feb. 25, 2014 /PRNewswire/ -- Benvenue Medical, Inc., today announced results of an independent, prospective, randomized study which found that the company's Kiva® VCF Treatment System was as effective as balloon kyphoplasty (BKP) in reducing pain associated with osteolytic vertebral body metastases. The Kiva System also resulted in no extravasation (cement leakage) while BKP, the current standard of care, showed a nearly 10 percent leakage rate. The results of the first head-to-head study of Kiva and BKP for this patient population were published online and in the Feb. 15 edition of the peer-reviewed journal Spine.
"Cement leakage is a common complication of balloon-assisted vertebral augmentation and can be disastrous for patients with bone metastases when it leaks into the spinal canal," said Panagiotis Korovessis, MD, PhD, Chief of the Department of Orthopaedic Surgery at General Hospital "Agios Andreas" in Patras, Greece, and lead author of the study. "This is the first study to show that the Kiva System is an effective alternative to BKP in providing spinal pain relief for these patients – and without the complication of cement leakage."
The study, titled "Is Kiva Implant Advantageous to Balloon Kyphoplasty in Treating Osteolytic Metastasis to the Spine? Comparison of 2 Percutaneous Minimal Invasive Spine Techniques," included 47 patients with 84 vertebral body osteolyses. Outcome measurements were vertebral body height, segmental kyphotic angle, extravasation rates, pain, function and quality of life. Results of the study include:
- Kiva and BKP provided equally significant spinal pain relief one month postoperatively, as measured by the Visual Analogue Scale and Oswestry Disability Index (P<0.001).
- No patients in the Kiva group experienced cement leakage, compared with 9.3% in the BKP group.
- Kiva and BKP showed a tendency for restoration of anterior and posterior vertebral body height and kyphotic Gardner angle; only Kiva restored middle vertebral body height.
- Both Kiva and BK safely augmented painful thoracic and lumbar vertebral osteolytic metastases; only Kiva additionally reinforced sacral metastases.
"This study adds to the body of literature demonstrating the effectiveness of the Kiva System, providing important insights for patients with cancer that has metastasized to the vertebra," said Robert K. Weigle, CEO of Benvenue Medical, Inc. "The Kiva System, which was cleared by the FDA in January, is continually proven to be an effective vertebral restoration treatment that reduces pain and improves quality of life for patients with cancer that has spread to the vertebra, but with the added patient benefit of reducing the risk of potential complications from cement leakage, which can be devastating."
About the Kiva VCF Treatment System
The Kiva VCF Treatment System provides a new, implant-based approach to vertebral augmentation in the treatment of painful VCFs. It is indicated 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.
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 during vertebral augmentation. The implant is delivered percutaneously 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 is physician-customized during the procedure.
The Kiva System received 510(k) clearance from the U.S. Food and Drug administration in January 2014. It is also available in Europe, where it is distributed by Zimmer.
About Benvenue Medical, Inc.
Founded in 2004, Benvenue Medical, Inc. develops next-generation, minimally invasive expandable implants for the spine. The company is privately held and funded by Versant Ventures, DeNovo Ventures, Domain Associates and Technology Partners. Its first products are designed for the treatment of vertebral compression fractures and degenerative disc disease, which have combined revenues of $1.6 billion globally. For more information, visit www.benvenuemedical.com.
SOURCE Benvenue Medical, Inc.