Benvenue Medical Reports Positive Independent Study Results

Officials for Santa Clara, Calif.-based Benvenue Medical Inc., claim that an independent, prospective, randomized study 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 cement leakage (technically called extravasation) 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, M.D., Ph.D., 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, as reported by Kiva, 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 percent 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; and
• 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. “The Kiva System, which was cleared by the FDA (U.S. Food and Drug Administration) 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.”

The Kiva VCF system provides an 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 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 also is available in Europe, where it is distributed by Zimmer.