Millions of people suffer from a hip fracture each year, noted the company, 20% of whom may sustain a contralateral hip fracture within five years of that incident. The risk of associated mortality can reach 64% five years after that. The Y-Strut is designed to preserve the quality of life and autonomy of patients who are at risk of a hip fracture.
The Y-Strut implant comprises two interlocking rods made from PEEK Optima supplied by Invibio (Thornton Cleveleys, UK), which are joined together with surgical cement. (A video of the procedure is available on the Hyprevention website.) Numerical and biomechanical tests showed significant improvement in fracture load (+18%) and energy-to-fracture (+32%) of the implanted femurs in comparison with intraindividual controls, according to a paper published in Clinical Biomechanics in May 2015.
The device is indicated for use in trauma, for the biomechanical reinforcement of the proximal femur in patients having incurred a low-energy trochanteric fracture on the other side, and in oncology, for percutaneous internal reinforcement of impending pathological fractures of the proximal femur, said Hyprevention CEO Cécile Vienney. PEEK Optima proved to be the ideal material for the device, Vienney explained to PlasticsToday.
"The PEEK Optima material, provided by Invibio, was chosen for its biomechanical performance similar to the normal cortical bone," said Vienney. "A biocompatible polymer currently used in orthopedic medical devices, PEEK Optima is perfectly adapted to our application that is bone strengthening in case of poor bone quality such as osteoporosis and osteolytic bone due to cancer."
Researchers and device manufacturers increasingly are seeking alternatives to metals to improve implant performance and address growing concerns related to metal ions, corrosion and wear, according to Invibio. PEEK polymer and composite technologies present a novel alternative, noted the company, which provides medical device OEMs with materials and processing development services, application-specific research and testing, and prototyping, validation and manufacturing of PEEK polymer and composite medical devices.
Hyprevention was formed in 2010 by Vienney and three orthopedic surgeons to develop, manufacture and market innovative implantable medical devices to address major public health issues. Thanks to the recent fund raising, it can now further develop its sales team and leverage opportunities in Europe, South America and the Middle East. In addition to pursuing clinical trials focused on patient benefit, the company also intends to perform health economy studies to support hip fracture prevention as a tool in curtailing healthcare costs.