Alpharetta, Ga., September 26, 2018 — Solvay, a leading global supplier of specialty polymers, announced today that the high stiffness, strength, gamma sterilization resistance and biocompatibility of its Ixef® polyacrylamide (PARA) resin helped enable a new single-use instrument kit for anterior cervical fusion procedures. Developed by Intelligent Implant Systems, a medical device company specializing in solutions for spinal surgery, the MEDIANT™ Anterior Cervical Plating System leverages Solvay’s advanced polymer to help boost operating room (OR) efficiency, eliminate onsite sterile processing and reduce infection risk.
“The primary benefit of Solvay’s Ixef® PARA in this application is its metal-like strength, which gives our single-use surgical instruments a very high level of performance without incurring the costs associated with machining metal and repeated steam sterilization,” said Marc Richelsoph, president and CEO of Intelligent Implant Systems. “Although PEI also offered viable options for our surgical tool kit, we specified Ixef® GS-1022 PARA because its superior stiffness and moldability was essential for the kit’s instruments.”
Ixef® GS-1022 PARA forms the awl and pin-screwdriver handles, measuring caliper, and locking plier handles in Intelligent Implant Systems’ kit. The polymer’s excellent impact resistance also eliminated the need for a metal strike plate that had been part of the awl’s early designs. This reduced the cost and simplified the manufacture and assembly of the instrument, further supporting the economics of single-use instruments.
Ixef® GS-1022 PARA provides excellent aesthetics, including an attractive surface finish. The material is available in a range of gamma-stabilized colors, including the signature green of the MEDIANT™ System’s tools. Together, these properties of Ixef® PARA ensure Intelligent Implant Systems’ single-use instruments retain their visual appeal after they are gamma sterilized and packaged for delivery. Solvay’s PARA polymer has been evaluated for ISO 10993 limited duration biocompatibility and is supported by an FDA Master Access File, which helped streamline the MEDIANT™ kit’s navigation through regulatory approvals.
“Solvay was an early advocate of the healthcare industry’s shift toward single-use surgical instruments, and we sought to support customers by proactively developing a broad portfolio of biocompatible polymer alternatives to metal – complete with gamma-sterilized colors and master access files,” said Jeff Hrivnak, business manager for Healthcare at Solvay’s Specialty Polymers Global Business Unit. “Yet while the industry’s growing adoption of our advanced polymers validates this early insight, we derive much greater satisfaction in working closely with innovators like Intelligent Implant Systems to help achieve unique new designs for improving patient results.”
Intelligent Implant Systems will feature the MEDIANT™ Anterior Cervical Plating System at Booth #1905 during The North American Spine Society (NASS) meeting in Los Angeles, Sept. 26-29. For related news about specialty polymers for healthcare, please go to www.solvayhealthcarenews.com.
® Ixef is a registered trademark of Solvay
™ MEDIANT is a trademark of Intelligent Implant Systems
Intelligent Implant Systems is based in Charlotte, NC. Founded in 2007, the company aims to develop and market innovative surgical solutions for orthopedics and both fusion and non-fusion applications of the spine. Since its inception, the company has been granted multiple U.S. patents with foreign and additional U.S. patents pending to protect its core technology. Innovation is truly part of what Intelligent Implant Systems brings to patients, surgeons, hospitals and ambulatory surgery centers. Learn more at www.intelligentimplantsystems.com.
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