KAST Pivotal Trial Results Plus other Published Comparative Studies Show Kiva Meets or Exceeds
Balloon Kyphoplasty Performance
San Diego, Calif, March 24, 2014 –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.” 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.
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.
“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.”
“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.
The KAST trial was conducted under an investigational device exemption (IDE) granted by the Food and Drug Administration (FDA). KAST was a prospective, multi‐center, randomized, controlled clinical trial designed to evaluate the safety and effectiveness of the Kiva® VCF Treatment System in comparison to the Medtronic KyphX System for balloon kyphoplasty, which is used in 85% of vertebral augmentation procedures, for the reduction and treatment of painful pathological compression fractures of the thoracic and lumbar spine that may have resulted from osteoporosis. The trial enrolled 300 patients at 21 medical centers in the United States, Canada, Belgium, France and Germany.
About the Kiva VCF Treatment System
The Kiva VCF Treatment System provides a new implant-based approach to vertebral augmentation in the treatment of painful VCFs. The Kiva System has a growing body of clinical evidence that demonstrates its advantages.
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 Kiva implant is designed to provide structural support to the vertebral body and direct and contain bone cement during vertebral augmentation. The unipedicular 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 minimally invasive procedure.
Kiva received 510(K) clearance from the FDA in January 2014, and it is also commercially available in Europe. Kiva 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
About Benvenue Medical, Inc.
Founded in 2004, Benvenue Medical, Inc. develops next-generation, minimally invasive expandable implants for the spine. The company is privately held and funded by Versant Ventures, DeNovo Ventures, Domain Associates and Technology Partners. Its first products are designed for the treatment of vertebral compression fractures and degenerative disc disease, which have combined revenues of $1.6 billion globally. For more information, visit www.benvenuemedical.com.
1Korovessis et al. Spine, February 2013
2Otten, Pflugmacher, et al. Pain Physician Journal, October 2013.
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