Benvenue Medical Celebrating Results of Kiva Study
Elizabeth Hofheinz, M.P.H., M.Ed. • Thu, March 13th, 2014
Benvenue Medical, Inc. has announced results of an independent, prospective, randomized study which found that the company’s KivaVCF 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% 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 February 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., in the February 25, 2014 news release. Dr. Korovessis is 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 BKP safely augmented painful thoracic and lumbar vertebral osteolytic metastases; only Kiva additionally reinforced sacral metastases.
Asked where the company hopes to be in a year with Kiva, CEO Robert K. Weigle told OTW, “With our full commercial launch happening this month, it’s hard to think about a year from now. What I can tell you is that the reception among physicians we’ve been talking to has been very positive and there is substantial interest in Kiva as a new, implant-based approach to vertebral augmentation.”
“We look forward to presenting the results from KAST, our FDA-approved pivotal trial, at the Society for Interventional Radiology on March 26. In addition to KAST, this recently published study in Spine adds to the growing breadth of independent clinical data that demonstrates Kiva’s effectiveness in treating VCFs, whether the fracture is caused by cancer, osteoporosis or trauma.”