Wednesday, March 31, 2021
NGMedical, a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application, announces FDA clearance for its anatomically shaped cervical interbody BEE® HA, made of the innovative PEEK-OPTIMA™ HA Enhanced from Invibio Biomaterial Solutions, a global leader in high-performance biomaterial solutions.
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, not coated, into the PEEK-OPTIMA™ matrix, making it available on all surfaces of the finished device. This is another significant innovation from the team, who recently launched the innovative additively manufactured BEE® cage.
"This is the next step for NGMedical to broaden our active market presence in the USA. We are proud having received the FDA clearance for our new BEE® HA. Our team did a great job in cooperation with MRC Global," says Dagmar Weiland, CEO 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," according to Josh Sandberg of NGMedical, Inc.
"More and more surgeons see PEEK-OPTIMA™ HA Enhanced solutions as their material of choice when faster, greater bone ongrowth 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," says John Devine, Invibio Biomaterial Solutions.