New Composite, New Nail, New Approval

CE-approved in 2009, the QUANTUM Humeral Composite Nailing System from N.M.B. Medical Applications Ltd has now been approved by the US Food and Drug Administration. The system is an innovative intramedullary interlocking nail made of ENDOLIGN from Invibio Biomaterial Solutions. This is an inherently pure and inert composite of continuous carbon fibres in a PEEK-OPTIMA polymer matrix that offers benefits that can advance the treatment of long bone fractures, says the company. Regulatory clearance was supported by biocompatibility data, Master File and other biomaterial and technical expertise provided by Invibio.

According to Elad Einav, Project Manager at N.M.B., Invibio’s biomaterial gives the QUANTUM Composite Nail more highly tailored elasticity, higher fatigue strength and MRI compatibility, which is helpful in the MRI fracture follow-up. In addition, the nail’s radiolucent properties enable fluoroscopic and CT visualisation of the bone fracture site during implantation as well as during follow-up. PEEK-OPTIMA’s proven, 10-year+ clinical history of safety as a raw material for implantable devices is another major advantage.

“The QUANTUM Nail is the first nail designed to treat long bone fractures that allows the surgeons to clearly see the fracture site and surrounding structures,” Einav added, “This is especially important in cancer cases where it is critical that the bone structures and soft tissue are visible in follow-up.”

ENDOLIGN composite is suitable for structural uses and the replacement of metals in high sustained or cyclic load applications requiring blood, bone or tissue contact of more than 30 days. Its
-tensile strength, stiffness and fatigue behaviour allows metal replacement in structural implants
-MRI, CT and X-ray compatibility allows artifact-free postoperative images and clear visualization of the healing site
-biocompatibility ensures safe, long-term implantation
-mechanical properties can be tailored to meet a wide range of needs.

Tags: Invibio, N.M.B. Medical Applications, QUANTUM Humeral Composite Nailing System