Last week we announced a first U.S. patient for Benvenue Medical’s novel Kiva® VCF Treatment System, an alternative to balloon kyphoplasty (BKP) in the treatment of vertebral compression fractures. Find that article here. Now Benvenue is trumpeting results of an independent, prospective, randomized study which found that the company’s Kiva® VCF Treatment System was as effective as BKP in reducing pain associated with osteolytic vertebral body metastases.
The results of this 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.
The study, entitled “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.
“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.”
“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.”
Source: Benvenue Medical, Inc., PR Newswire