In February (2014) we covered the news that Benvenue Medical was making some noise about the results of an independent, prospective, randomized study which found that the its Kiva® VCF Treatment System was as effective as Balloon Kyphoplasty in reducing pain associated with osteolytic vertebral body metastases. One month on, the company has announced the full commercial launch of its system, supported by further favourable clinical data.
Background
Benvenue made its announcement at the Society for Interventional Radiology Annual Scientific Meeting, where results from KAST (Kiva System as a Vertebral Augmentation Treatment – A Safety and Effectiveness Trial) are being presented. According to Benvenue, the KAST results demonstrate the Kiva System met or exceeded the performance of the Medtronic balloon kyphoplasty (BKP) system, the current standard of care in treating vertebral compression fractures (VCFs), on every endpoint measured. These results add to the growing body of peer-reviewed evidence favoring Kiva’s performance over BKP. The Kiva System is a novel implant-based solution for vertebral augmentation and a next-generation alternative to BKP, making it the first clinically proven new approach to the treatment of VCFs in over a decade.
The Kiva System features a proprietary, cylindrical implant made from a medical polymer that is designed to provide a very predictable structural support for the vertebral body and a reservoir to contain and direct the flow of bone cement. This new implant approach allows the treating doctor to deliver a much more consistent result. BKP inserts a bolus of bone cement directly into a vertebral cavity without an implant to hold it, making the control of the bone cement less predictable. As part of its commercial launch, Benvenue Medical filled its training schedule at SIR with physicians from all over the U.S. participating. The company continues to expand its direct sales distribution, network of physicians using Kiva and hospital contracting agreements in response to initial demand.
Combined with KAST, Kiva has been shown in at least three comparative studies with a total of more than 500 patients to meet or exceed BKP’s performance on safety and efficacy, adjacent level fracture rate, Kyphotic Angle restoration (curvature of the spine), cement extravasation rate (cement leakage into surrounding tissue) and cement volume1,2,.
Investigator comments
“The Kiva System was clinically proven in KAST, as well as in several other trials, to be better than or similar to balloon kyphoplasty, which is our most widely offered treatment,” said Sean M. Tutton, MD, FSIR, Co-Principal Investigator in the KAST Study and Professor of Radiology and Surgery at the Medical College of Wisconsin in Milwaukee. “KAST sets the new standard for future trials in the VCF category. KAST results, in addition to the results of the other trials conducted, demonstrated the Kiva implant has important advantages for our patients and will serve as future guidance in clinical decision-making between VCF treatment options.” The KAST abstract, “KAST Study: The Kiva System as a Vertebral Augmentation Treatment—a Safety and Effectiveness Trial,” is being highlighted by SIR at its annual meeting in San Diego.
Physician comments
“I was excited to introduce Kiva to my VCF patients because the wealth of clinical data show it addresses some of the shortcomings of BKP,” said Wayne Olan, MD, interventional neuroradiologist and Director of Interventional & Endovascular Neurosurgery at GW Hospital. Dr. Olan was the first in the U.S. to treat VCF patients with Kiva following its clearance by the U.S. Food and Drug Administration. “It was an easy decision to offer the most advanced VCF treatment available today, especially when it is proven under the highest scientific standards.”
Company comments
“We are excited to provide a new alternative to the large and growing population of VCF patients in the U.S. market.” said Robert K. Weigle, CEO of Benvenue Medical, Inc. “We believe the enthusiastic response we’re enjoying is a result of, among other things, the fact that government and private payers are pushing to ensure treatment effectiveness in their reimbursement decisions, and we have a growing body of peer-reviewed data that show Kiva’s clinical benefits over BKP.”
Source: Benvenue Medical, Inc.
published: March 24, 2014 in: Launches / Withdrawals, Spine