Benvenue Medical has completed enrolling patients in its Kiva System as a Vertebral Augmentation Treatment - A Safety and Effectiveness Trial (KAST).
Kiva system, which features a proprietary flexible Kiva implant, is designed to reduce polymethyl methacrylate (PMMA) bone cement volume, adjacent level vertebral fractures, extravasation rate as well as to preserve cancellous bone structure.
The Kiva implant made of Peek-Optima polymer is delivered percutaneously over a removable guidewire to provide structural support to the vertebral body and to directionally control and contain bone cement.
The controlled, randomized, trial, which has enrolled 300 patients over 21 medical centers in the US, Canada, Belgium, France and Germany, is designed to compare Kiva System to Medtronic’s Kyphon balloon kyphoplasty.
The primary endpoint includes non-inferiority on composite of pain, function, and safety at one year of follow-up, while secondary endpoint includes superiority on PMMA cement volume, extravasation rate and height restoration.
Medical College of Wisconsin radiology and surgery professor and KAST study co-principal investigator Sean M. Tutton said "The KAST study enrolled ahead of schedule, and we believe the positive response we received is due to our investigators’ enthusiasm for a new treatment option for painful and debilitating osteoporotic vertebral fractures moving away from traditional vertebroplasty or balloon-based vertebral augmentation."
Benvenue Medical CEO Robert K. Weigle said, "We continue to work very closely with the FDA, and we are pleased with the collaboration and progress we have made working together."
The company said it will use the data of KAST study to file to the US Food and Drug Administration (FDA) for market clearance.