NGMedical, a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application, received FDA clearance for its anatomically shaped cervical interbody BEE HA.
BEE HA was developed to optimize fusion while maintaining elasticity that is similar to bone and radiolucency of the cage body. Hydroxyapatite (HA), a well-known osteoconductive material that enhances bone apposition, is fully integrated into the PEEK-OPTIMA matrix, making it available on all surfaces of the finished device.
Dagmar Weiland, CEO, NGMedical, said: “This is the next step for NGMedical to broaden our active market presence in the USA. We are proud to have received the FDA clearance for our new BEE HA. Our team did a great job in cooperation with MRC Global.”
According to Josh Sandberg of NGMedical, “The clearance of the BEE HA cage is an important step to complete our portfolio with this innovative solution. This implant, along with its streamlined and elegant instrumentation, is perfectly suited for the U.S. surgeon as it addresses artifact-reduced imaging while enhancing fusion.”
John Devine, Invibio Biomaterial Solutions, said: “More and more surgeons see PEEK-OPTIMA HA enhanced solutions as their material of choice when faster, greater bone on growth is essential. The clinical evidence for PEEK-OPTIMA HA enhanced devices demonstrates consistently good outcomes when compared to other materials, so we are excited for NGMedical to launch the BEE HA cage in the U.S. and the potential for enhancing patient care.”