Hyprevention received FDA 510(k) clearance for the V-STRUT© Vertebral Implant, indicated for the treatment of vertebral fractures.
V-STRUT is indicated for the treatment of vertebral compression fracture due to osteoporosis or tumorous bone lesions in the thoracic or lumbar spine. Two implants, made of PEEK polymer, are inserted in the vertebral body through the pedicles and combined with PMMA bone cement.
V-STRUT features a pedicle anchorage designed to distribute vertebral load between anterior and posterior columns to reduce subsequent and adjacent fractures. The device adapts to bone stiffness and is combined with PMMA bone cement for fracture fixation, implanted in a minimally invasive procedure.
Hyprevention is launching V-STRUT in the U.S., where they have already initiated a medical education program and look forward to quickly expanding their distribution network.
“We are thrilled to make our first step in the US market and provide patients and physicians with V-STRUT, a truly novel and cost-effective solution to treat a broad spectrum of vertebral fractures,” said Cécile Vienney, CEO.