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Commercial launch of Kiva VCF

Manufacturing Group | March 28, 2014

KAST pivotal trial results plus other published comparative studies show Kiva meets or exceeds balloon kyphoplasty performance.

Commercial launch of Kiva VCF

San Diego, California –Benvenue Medical Inc. announced the full commercial launch of the Kiva VCF Treatment System for the reduction and treatment of spine fractures 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. KAST results demonstrated 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. “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.”

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 volume[1,2]

 “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. 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.” 

“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.”

VCFs occur when a vertebra (bone in the spine) cracks, fractures or collapses. Over the last 10 years, the approaches to treating VCFs have included conservative therapies or vertebral augmentation, traditionally performed with balloon kyphoplasty or vertebroplasty. VCFs are most often caused by osteoporosis, and there are 750,000 osteoporosis-related vertebral compression fractures annually in the U.S. alone, representing a large patient population, which is only expected to continue growing as the population ages. Other causes of VCFs include malignant bone tumors and trauma.

Source: Benvenue Medical

[1] Korovessis et al. Spine, February 2013.

[2] Otten, Pflugmacher, et al. Pain Physician Journal, October 2013.

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