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By Omar Ford

Staff Writer

Five years of gathering and collecting clinical evidence is paying off for Benvenue Medical (Santa Clara, California). This week the company got to see the size of the payoff, during the annual scientific meeting for the Society for Interventional Radiology (Fairfax, Virginia) held in San Diego. The firm not only received positive support for its Kiva VCF treatment system, which is indicated for use in the reduction and treatment of spinal fractures in the thoracic and/or lumbar spine, but it also had a full commercial launch of the product. To top it off, the company reported results from the Kiva System as a Vertebral Augmentation Treatment – A Safety and Effectiveness Trial.

"We're in our little booth [at the conference] and we're surrounded by companies that have balloon kyphoplasty products," Robert Weigle, CEO of Benvenue, told Medical Device Daily. "Literally there are six companies right around our booth and from our viewpoint we can point to them all. There's no discernible difference between any of them. Then along comes Benvenue with the new implant technology and with clinical data showing distinct clinical benefits and outcomes. You can imagine the response. We're getting physicians coming to the booth saying that this really makes sense. They're saying that they want to learn this technique."

The Kiva System features a 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. The company said that this new implant approach allows the treating doctor to deliver a much more consistent result than traditional efforts.

Balloon kyphoplasty 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.

"The approach for the placement of our implant into the vertebral body is the same as it is for balloon kyphoplasty, in fact it's simpler," Weigle said. "With balloon kyphoplasty it requires two sticks into the opposing sides of the vertebral body. Our device uses only one approach and you get a uniform predictable implant within the vertebral body through single access. Physicians really like that. It was demonstrated in our study that the time for our procedure was equal to or less than the current standard of care."

KAST results demonstrated the Kiva System met or exceeded the performance of the Medtronic (Minneapolis) balloon kyphoplasty system, the current standard of care in treating vertebral compression fractures, on every endpoint measured. These results add to the growing body of peer-reviewed evidence favoring Kiva's performance over balloon kyphoplasty.

The KAST trial was conducted under an investigational device exemption granted by the 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 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 Tutton, MD, FSIR, Co-Principal Investigator in the KAST Study and Professor of Radiology and Surgery at the Medical College of Wisconsin (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."

As part of its commercial launch, Benvenue filled its training schedule at the Society for Interventional Radiology conference 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.

"I think timing is everything," Weigle said. "We have worked very hard over the last five years amassing clinical data, which none of our competitors have done. We now have three studies with over 500 patients that show clinically meaningful benefits with our device vs. a balloon technology."

Weigle noted that there is a huge market opportunity for Kiva.

"The opportunity here is a vast one," he said. "There are close to a million patients that suffer vertebral fractures here in the U.S. Primarily these patients are women, over the age of 50. When these fractures occur it's extremely painful and leaves the person bed ridden. You basically lose your life and independence. The whole idea of a treatment like ours is to get these patients back to daily activities pain-free. This is a big problem and it's one that's growing. As someone said to me yesterday, there's a silver tsunami coming. We're all aging. There's no magic pill for the treatment of osteoporosis. To have a treatment such as the Kiva treatment, is a great benefit for these potential patients."

Published  March 27, 2014

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