SANTA CLARA, Calif.–(BUSINESS WIRE)–Benvenue Medical, Inc., a developer of minimally invasive solutions for spine repair, today announced that the Kiva® VCF Treatment System, a novel implant for treating vertebral compression fractures (VCFs), resulted in substantial cost and resource savings in the hospital setting over balloon kyphoplasty (BKP) — the current standard of care — in an economic analysis published online in the May/June issue of Pain Physician. These savings were achieved as a result of positive clinical outcomes documented in the KAST study, the largest randomized, controlled, clinical trial to date versus the standard of care recently published online in Spine.
The study, “Economic Analysis of Kiva® VCF Treatment System Compared to Balloon Kyphoplasty Using Randomized Kiva Safety and Effectiveness Trial (KAST) Data,” analyzed clinical data from KAST (which was conducted under an IDE granted by the FDA), augmented with unit-cost data from the published literature. The VCF surgery, device and other medical costs were compared between the Kiva System and BKP. Study authors concluded use of the Kiva System will result in a direct medical cost savings of $1,118 per patient and $280,876 per hospital.“Traditional procedures for treating vertebral compression fractures, such as vertebroplasty and balloon kyphoplasty, have been well documented to be safe, effective and cost efficient,” said Wayne J. Olan, MD, Director of Minimally Invasive and Endovascular Neurosurgery at the George Washington University Medical Center and author of the study. “This study shows that the Kiva System is a further improvement in terms of both patient care and cost effectiveness. The more than 30 percent reduction in adjacent-level fractures shown in the KAST trial with Kiva translates directly to fewer reoperations for the patient and reduced costs for the hospital relative to balloon kyphoplasty.”
“In today’s healthcare environment, new technology must both improve patient outcomes and add economic value for our facility,” said J. Kevin McGraw, MD, Medical Director Interventional Radiology at Riverside Methodist Hospital, and a new Kiva user. “This study clearly demonstrates actual cost savings of using Kiva vs. balloon kyphoplasty in the long term. Not only does Kiva provide improved patient outcomes but now we know Kiva is also cost effective.”
“The economic implications of this study demonstrate how the Kiva System is beneficial for both VCF patients and hospitals,” said Robert K. Weigle, CEO of Benvenue Medical, Inc. “Along with improving clinical outcomes and increasing patient satisfaction, we now know the Kiva System provides significant cost savings for hospitals during a pivotal time when healthcare decision makers must optimize allocation of limited resources.”
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. It 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.
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 a reservoir to direct and contain bone cement during vertebral augmentation. The 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 procedure.
The Kiva System received 510(k) clearance from the U.S. Food and Drug administration in January 2014.
About Benvenue Medical, Inc.
Founded in 2004, Benvenue Medical, Inc. provides next generation minimally invasive systems for spine repair that combine expandable implants with novel delivery instruments to provide enduring functional benefits for patients. The company is privately held and funded by InterWest Partners, 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 $9 billion globally. For more information, visit www.benvenuemedical.com.
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Betsy Merryman
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