BELGIUM – Solvay, a leading global supplier of specialty polymers, has announced that its Ixef polyarylamide (PARA) resin delivered the high stiffness and biocompatibility system.
The system was needed by Reign Medical to develop its revolutionary new Clench compression staple system, a single-use bone staple kit for orthopedic procedures targeting the hand and foot.
According to the company, the Reign Medical’s innovative Clench Staple System kit comprises a fully disposable sterile surgical tool set for fixating hand and foot bone fragments, osteotomy fixation and joint arthrodesis.
Its design utilizes a patented threaded hub that allows surgeons to incrementally expand the implant for proper insertion, while retaining the mechanical properties of the Nitinol staples for continuous compression across the fusion site after implantation.
The company specified Solvay’s Ixef GS-1022 PARA, a 50-percent glass fiber-reinforced grade, for several components: the implant sizer, the drill guide and each part of the implant delivery instrument, including its handle, the saddle on which the staple sits, and the threaded compressor that forces the staples fully open.
The mechanical strain on these components requires them to be molded from a very high-stiffness material, and Solvay’s Ixef PARA GS-1022 compound proved to be the optimal solution.
Offering metal-like strength, rigidity and dimensional stability, this biocompatible polymer also provides an exceptional surface finish.
Available in a range of gamma-stabilized colors, Ixef PARA is optimized for sterilization using high-energy gamma radiation, showing no significant change in appearance or performance after sterilization.
The material has been evaluated for ISO 10993 limited duration biocompatibility and is supported by an FDA Master Access File.
“Our impetus for this kit was to develop a more robust, single-use bone fixation system than currently available,” said Daniel Lanois, the development engineer for Reign Medical’s Clench® Staple System.
“Many competitive solutions use lower performing plastics that do not reliably withstand the force required to hold Nitinol staples open, causing the staples to disengage prematurely.
After briefly considering polycarbonate and ABS blends, we chose Ixef PARA primarily for its outstanding stiffness, which enabled even the smaller components of the delivery tool to reliably withstand the compression of the staples as well as the torsional, tamping and axial loads applied during fixation procedures.”
Reign Medical’s single-use Clench Staple System received FDA clearance in early April this year.
The company is now undergoing the beta test for its first production launch.
“Solvay’s practice of open innovation promotes the success of customers like Reign Medical by enabling them to focus on their medical device design while we help navigate issues related to materials science and molding challenges,” said Jeff Hrivnak, business manager for Healthcare at Solvay’s Specialty Polymers Global Business Unit.
“Solvay also conducted a crystallinity study of molded prototypes of Clench system components to validate the tool and ensure that parts were molded properly.”