Benvenue Medical has completed the enrolment of patients in its Kiva System as a Vertebral Augmentation Treatment - A Safety and Effectiveness Trial (KAST), designed to compare the system to Medtronic's Kyphon balloon kyphoplasty.
The Kiva System, which features a proprietary flexible implant, is designed to reduce polymethyl methacrylate (PMMA) bone cement volume, adjacent level vertebral fractures, extravasation rates and preserve cancellous bone structure.
Delivered percutaneously over a removable guidewire, the Kiva implant made of Peek-Optima polymer, is designed to provide structural support to the vertebral body and to directionally control and contain bone cement.
The controlled, randomised trial has enrolled 300 patients in 21 medical centres in the US, Canada, Belgium, France and Germany to demonstrate the safety and efficacy of system.
The primary endpoint includes non-inferiority on composite of pain, function and safety at one year of follow-up, while secondary endpoints include superiority on PMMA cement volume, extravasation rate and height restoration.
Sean M. Tutton, Medical College of Wisconsin radiology and surgery professor and KAST study co-principal investigator, 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."
Steven R. Garfin, University of California department of orthopaedic surgery professor and chairman and KAST study co-principal investigator, said: "The results will be important to guiding treatment recommendations for VCFs."
Robert K. Weigle, Benvenue Medical CEO, 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 data from KAST study will be useful for filing for market clearance from the US Food and Drug Administration (FDA), according to the company.