By Varun Saxena
Spinal specialist Benvenue Medical is taking on Medtronic ($MDT). The smaller company boasted of clinical trial results showing that its FDA-cleared Kiva VCF System to treat vertebral compression fractures (VCFs) performs as well as or better than the industry bigwig’s KyphX System.
VCFs are associated with osteoporosis. Both companies say their devices are in the coveted minimally invasive category.
Dubbed KAST, the international comparative clinical trial of 300 osteoporotic patients concluded early because the Kiva’s primary endpoint of noninferiority to the KyphX System was met before full enrollment, Silicon Valley’s Benvenue said. Specifically, the 12-month endpoint was defined as a reduction in fracture pain using a questionnaire, improvement in function on a disability index, and absence of serious adverse events.
Benvenue CEO Robert Weigle said in a statement that Kiva now has the most head-to-head comparison data of devices in the VCF arena. And according to the study published in the journalSpine, Kiva showed signs of outperforming the KyphX when it comes to new reducing spinal fractures following the procedure.
Medtronic’s device uses balloon kyphoplasty, which involves the inflation of a balloon within a damaged or compressed vertebrae in order to restore its original height, according to a study.
