N.M.B. Medical Applications of Herzeliya, Israel won FDA approval to market its QUANTUM Composite Nailing System, an intramedullary system designed for treatment of long bone fractures. The nail is made of a composite material called Endolign, developed by Invibio of Lancashire, UK, reinforced by carbon fiber, so the whole system is compatible for MRI during follow-ups. The nailing system already received European CE Mark of approval and will now be also marketed in the US.
ENDOLIGN is an inherently pure and inert composite of continuous carbon fibers in a PEEK-OPTIMA® polymer matrix, to enable patient/surgeon benefits and advance the treatment of long bone fractures.
The nail’s radiolucent properties enable fluoroscopic and CT visualization of the bone fracture site during implantation as well as during follow-up. PEEKOPTIMA’s proven, 10-year+ clinical history of safety as a raw material for implantable devices is another major advantage.
The radiolucent QUANTUM Composite Nail incorporates longitudinal marking for easy insertion, positioning and
follow-up. Radiopaque markers over the distal interlocking holes enable easier drill trajectory adjustment. A propriety disposable radiolucent drill drive is also available.
Excellent tensile strength, stiffness and fatigue behavior 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.
Press release: N.M.B. Medical Applications Ltd. Obtains FDA Clearance for Marketing its ENDOLIGN-Made QUANTUM Composite Nailing System for Treatment of Humeral Fractures….
Product pages: Quantum Composite Nailing System…; ENDOLIGN Composite…