Hyprevention has started in the US to introduce their new product V-STRUT with Dawa Medical LLC. March 2020, Hyprevention received FDA 510(k) clearance for the V-STRUT© Vertebral Implant, indicated for the treatment of vertebral fractures.
V-STRUT© Vertebral implant is an unique new product indicated to treat vertebral fractures using pedicle anchorage and material close to the normal bone.
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.Medical device. FDA cleared (class II). CE mark pending.
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.
Features:
- Pedicle anchorage for endplate support
- Cement distribution control
- Easy and safe surgical technique (no technical challenge)
Benefits:
- Biomechanical Performance
- PERCUTANEOUS Insertion: V-STRUT® is implanted through a percutaneous procedure with a dedicated instrumentation kit for an easy and safe surgical technique. Vertebral height restoration is done pre-operatively by patient positioning1-3.
- The cement distribution is controlled through the implant.
- Range of Size to Fit T9 to L5 anatomies
About Hyperprevention
Founded in 2010 by Cécile Vienney (CEO) and 3 orthopedic surgeons, Hyprevention is a start-up located in Bordeaux-France that develops, manufactures and markets implantable medical devices. For more information please visit www.hyprevention.com
About Dawa Medical
Dawa Medical is a consulting company whose primary goal is to bring efficiency, efficacy, and simplicity to its clients. In order to accomplish these results, we provide solutions for manufacturers and distributors to develop a mutually beneficial business relationship, as well as other services. By establishing these relationships, our clients are better-able to work efficiently by focusing on their products instead of searching for qualified distributors and negotiating contracts.For more information please visit https://dawamedical.com