Study Results Claim Cost Savings from Benvenue Medical’s Kiva Spine System

A recent study touted by Benvenue Medical Inc., a developer of minimally invasive solutions for spine repair, seems to indicate that the company’s Kiva VCF treatment system, an implant for treating vertebral compression fractures (VCFs), resulted in cost and resource savings in the hospital setting when compared to balloon kyphoplasty (BKP)—the current standard of care. An economic analysis was published online in the May/June issue of the journal Pain Physician.

According to the company, the 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 the journal Spine.

“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, M.D., director of minimally invasive and endovascular neurosurgery at the George Washington University Medical Center in Washington, D.C., 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.”

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 investigational device exemption granted by the U.S. Food and Drug Administration (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.

“In today’s healthcare environment, new technology must both improve patient outcomes and add economic value for our facility,” said J. Kevin McGraw, M.D., 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. “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 health care decision makers must optimize allocation of limited resources.”

Kiva VCF system provides an 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 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 system received 510(k) clearance from the FDA in January 2014.

Founded in 2004, Santa Clara, Calif.-based Benvenue Medical is privately held and funded by InterWest Partners, Versant Ventures, DeNovo Ventures, Domain Associates and Technology Partners.