PESSAC, France--(BUSINESS WIRE)--Hyprevention® receives CE Mark approval for Y-STRUT®, an implantable medical device designed to prevent hip fracture. Hyprevention® is now ready for commercial deployment in Europe.
About Y-STRUT®
Y-STRUT® is an implantable medical device indicated to prevent fractures of the proximal femur. It is intended to be used in two clinical indications:
- Traumatology, for contralateral percutaneous internal fixation of proximal femur, in patient with a low energy pertrochanteric fracture on the first side,
- Oncology, for percutaneous internal fixation for impending pathological fracture of proximal femur. Act of last resort (ultima ratio).
Y-STRUT® is implanted thanks to a minimally invasive procedure by an orthopedic surgeon or an interventional radiologist.
14 patients already successfully benefited from Y-STRUT® technology in the clinical trials jointly conducted at the University Hospital of Bordeaux, the Gustave Roussy Institute in Paris and at the University Hospital Brugmann in Brussels.
Y-STRUT® development was supported by BPIFrance and the Regional Council of Aquitaine.
About Hyprevention®
Founded in 2010 by Cécile Vienney (CEO) and 3 orthopedic surgeons, Hyprevention is a French company that develops, manufactures and sells implantable medical devices to address unmet clinical needs. It is certified ISO 13485: 2003 since January 2014, and CMDCAS since January 2015.