Study Demonstrates Clinical Advantages of Kiva Over Balloon Kyphoplasty

The Kiva VCFTreatment System is a better treatment for back pain than balloon kyphoplasty, an independent evaluation has concluded.

A peer-reviewed study compared the safety and effectiveness of balloon kyphoplasty with the Kivasystem developed by Benvenue Medical Inc. In addition to significant improvements in back pain, the Kiva system also resulted in significantly fewer new fractures and half the mean cement used as compared to balloon kyphoplasty.

The study results were published online and in Pain Physician Journal, the official publication of the American Society of Interventional Pain Physicians. Benvenue claims the study is the second to be published this year that demonstrates Kiva’s efficacy.

“Historically, balloon kyphoplasty has offered my osteoporotic VCF [vertebral compression fracture] patients benefits. We evaluated Kiva as a new treatment option to see if those benefits were improved,” said Lucia Otten, University Hospital in Bonn, Germany, and study author. “Patients in our study treated with Kiva experienced a pronounced improvement in back pain over balloon kyphoplasty. Additionally, patients treated with Kiva demonstrated a lower incidence of newly occurring fractures and we used less than half the cement.”

“This study indicates that using Kiva to treat VCFs offers statistically significant advantages over balloon kyphoplasty in addressing pain, as well as in improving longer-term results by reducing future fractures,” said Robert Pflugmacher, M.D., professor of surgery at the University Hospital in Bonn, Germany.

The study, titled “Comparison of Balloon Kyphoplasty with the New Kiva VCF System for the Treatment of Vertebral Compression Fractures,” was conducted on the basis of matched pairs, with 52 patients suffering from 68 osteoporotic fractures and followed for six months. Those treated with balloon kyphoplasty were treated with KyphX-Systems by Medtronic Inc., the most common vertebral augmentation treatment in the United States. Outcome measurements were Visual Analog Scale (VAS, a measure of pain), Oswestry Disability Index (ODI, a measure of function), cement usage, cement extravasation, height restoration, and new fractures. The study concluded several statistically significant outcomes in favor of Kiva over balloon kyphoplasty:

• Pain improvement was significantly better with Kiva at 6 months (p < 0.0001);
• New fractures following treatment with Kiva were significantly lower, 12 percent, than after balloon kyphoplasty, 54 percent (p < 0.0001);
• Mean cement used was less than half with Kiva (2.2 – 2.6 mL) vs. balloon kyphoplasty (4.7 – 7.5 mL); and
• Although not demonstrated in the study to be a statistically significant difference, cement extravasation was less with Kiva (23 percent) vs. balloon kyphoplasty (31 percent). Vertebral height restoration and functional improvement were equivalent in both groups.

“‘This is the first independent study to show that the Kiva system was better at improving pain and reducing subsequent fractures in patients with VCFs than balloon kyphoplasty. But it’s the second to show significant clinical advantages of using Kiva over balloon kyphoplasty,” Benvenue Medical CEO Robert K. Weigle said.

Commercially available in Europe, the Kiva system is distributed by Zimmer Spine. Kiva is investigational in the United States and is the subject of a pending 510(k).

The National Osteoporosis Foundation estimates there are 700,000 osteoporosis-related vertebral compression fractures annually in the United States, yet only 200,000 kyphoplasty procedures are performed globally.

The Kiva VCF Treatment System features a proprietary flexible implant made from PEEK-Optima, a biocompatible polymer widely used in spinal implants. The Kiva implant is designed to function as a mechanical support structure and a reservoir to contain and direct the flow of bone cement.

The implant is delivered percutaneously in a continuous loop into the vertebral body through a small diameter, single incision. The amount of the Kiva implant delivered can be physician-customized during the procedure to adjust to various fracture types. Delivered over a removable guidewire, the implant is designed to provide structural support to the vertebral body and to directionally control and contain bone cement.

The minimally invasive Kiva system is designed to reduce polymethyl methacrylate bone cement volume; preserve cancellous (porous and mesh-like, as opposed to dense) bone structure; reduce adjacent level vertebral fractures; and reduce extravasation rate (leakage into surrounding tissue).

Founded in 2004, Benvenue Medical Inc. develops next-generation, minimally invasive expandable spinal implants. The company is privately held and funded by De Novo Ventures, Domain Associates, Technology Partners and Versant Ventures. 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.