Article preview from Medtech Insight Newsletter - October 28, 2013
At the recent CIRCE meeting, researchers presented positive clinical data comparing Benvenue Medical Inc.’s Kiva vertebral compression fracture system versus Medtronic’s market-leading Kyphon kyphoplasty system, providing a boost for Benvenue, which is awaiting FDA 510(k) clearance of its device.
Medical Touts Next-Generation Treatment For Vertebral Compression Fractures
Article preview from Medtech Insight Newsletter - October 28, 2013
Several emerging companies are attempting to capitalize on the growing vertebral compression fracture (VCF) market, including Santa Clara, CA-based Benvenue Medical Inc., which recently announced some important clinical and regulatory milestones.
In the US, a 510(k) is currently pending for the clearance of Benvenue’s Kiva VCF Treatment System. The single-use deployment system consists of a special guidewire to deliver a flexible implant into the vertebral body. The customizable implant assumes a circular, stacked coil shape of up to four loops as it is incrementally introduced into the vertebral body. The implant is designed to provide structural support and to contain and direct the flow of polymethyl methacrylate (PMMA) bone cement.
Benvenue is initially targeting patients with VCFs due to osteoporosis, which primarily affects women over the age of 50. “There are approximately 700,000 patients in the US who suffer these debilitating vertebral fractures,” says Benvenue’s CEO, Robert Weigle.
According to Weigle, the two options today for VCF are either conservative care (essentially bed rest with bracing and pain medications) or vertebroplasty/vertebral augmentation. “Since 1995, vertebral augmentation has become the standard of care,” he notes, whereby a balloon is inserted inside the fractured vertebra and expanded to create a void, and bone cement then is injected to fill the void. “The whole idea is to reduce pain immediately, restore function, and regain your quality of life as soon as possible. This has been quite successful to date for treatment of patients who suffer from these compression fractures of the vertebra, primarily due to osteoporosis.”
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