PESSAC, France, Oct. 12, 2020 /PRNewswire/ -- Hyprevention team is pleased to announce the first clinical cases performed in the USA with the V-STRUT© Vertebral Implant product to treat vertebral fractures. The FDA cleared V-STRUT© Vertebral Implant is indicated for use in the treatment of vertebral fractures due to osteoporosis or bone metastasis.
Two elderly patients presenting with osteoporosis and severe pain were selected by Dr Douglas BEALL, Chief of Radiology Services at Clinical Radiology of Oklahoma, to receive the V-STRUT© Vertebral Implant treatment.
"The unique pedicle anchorage, with the V-STRUT© design, shares the load between the vertebral body and the pedicles. The surgical technique is easy and comprehensive and works like a charm. The implant provides good control of the bone cement injection and both treatments were completed in approximately 25minutes. The two patients tolerated the surgery well and the clinical results were outstanding", says Dr Douglas BEALL.
The Hyprevention team has commenced the commercialization of the V-Strut implant device in the United States. The V-STRUT© device is now available in Oklahoma, Texas, Louisiana, New Jersey, Pennsylvania, Maryland, Delaware and Florida.
V-STRUT© Vertebral Implant is an implantable medical device made of INVIBIO PEEK Optima® polymer indicated for use in the treatment of vertebral fractures in the thoracic and lumbar spine. It is intended to be used in combination with Teknimed F20® bone cement. V-STRUT© is patented and cleared in the USA. The device was developed with the support of Key Opinion Leaders in the spine surgery. A deep literature review allowed to identify unmet clinical needs such as subsequent and adjacent fractures after treatment in osteoporotic and cancer patients. The device was developed to address this clinical need thanks to its soft material, close to normal bone, and an unique pedicle anchorage. The US patent was granted for V-STRUT© in May 2019.
Hyprevention was founded in 2010 in France by 3 orthopedic and spine surgeons and an experimented Executive Team. The company aims to develop innovative products addressing bone fragility as the consequence of osteoporosis and bone metastasis, thanks to the unique technique STRUTPLASTY® intended to reinforce the bone with polymer implant combined with bone cement.
Cécile VIENNEY, CEO, [email protected]