FH Group extends Total Disc Replacement Product Lines with DSM’s Bionate® PCU
DSM Biomedical, a global leader in biomedical materials science, today announced the company has entered into a licensing agreement with orthopedic device manufacturer and distributor, FH Group.
The agreement grants FH Group the use of Bionate® PCU, a proprietary DSM Biomedical polymer, in its LP-ESP® (lumbar) and CP-ESP® (cervical) disc replacement products. DSM Biomedical’s Bionate PCU was chosen as the material for the disc replacement elastomer core based on its biocompatibility and elastomeric quality, enabling the implant to mimic motion of the human disc.
In 2006, the LP-ESP received CE Mark approval and the first clinical implantations were performed. Currently, LP-ESP is used worldwide and offers one of the longest clinical histories of any elastomer disc replacement, with over three years of clinical follow-up.
“The development of the technology was a research-intensive, 10-year process that involved collaboration among a number of esteemed groups, individuals and companies including Commissariat à l'Energie Atomique – the most prestigious French government-funded technological research organization in cooperation with Professor Roy Camille of the renowned La Pitié hospital in Paris and Université Pierre et Marie Curie in Paris (UPMC),” said J.M. Idier, CEO, FH Group. “DSM Biomedical played a pivotal role in the process by providing biocompatible Bionate PCU for this spinal implant,” he added.
“DSM Biomedical has been very successful in expanding our collaborative relationships with medical device manufacturers looking to extend their product offerings with novel or next generation devices,” said Rob Evans, Global Business Director, Biomaterials, DSM Biomedical. “We are excited about our work with FH Group, an organization which shares our company’s vision to deliver products that work to improve clinical outcomes for patients.”
About FH Group
FH ORTHOPEDICS designs and manufactures high-quality medical devices for orthopedic, trauma and spine applications. Headquartered in France with global operations and distribution, FH Orthopedics has a 40-year history of collaborating with expert surgeons, leading hospitals and development partners to bring innovative orthopedic solutions to market across a broad range of applications. The company’s portfolio includes two elastomeric total disc replacements designed to address lumbar and cervical pathologies. Key product brands for the spine are the LP-ESP and CP-ESP. In other fields, flagship products include the TLS® for ACL and PCL repair and the ARROW® and TELEGRAPH® for Shoulder arthroplasty and trauma.