Solvay’s Ixef® PARA offers alternative to stainless steel in Innovative Surgical Designs’ new Redi-Spine™ system for spinal fusion surgical procedures.
Alpharetta, Ga., October 2, 2018 --- Solvay, a leading global supplier of specialty polymers, announced during NASS 2018 last week that Innovative Surgical Designs, a developer and manufacturer of orthopedic spinal systems, chose Ixef® polyarylamide (PARA) resin to innovate a new single-use surgical instrument kit for minimally invasive spinal fusion surgery. Innovative Surgical Designs’ new Redi-Spine™ kit leverages Ixef® PARA’s mechanical strength, moldability and gamma sterilizability to offer an economical alternative to reusable stainless steel instruments.
“Ixef® PARA’s metal-like strength and rigidity enabled us to simplify and deliver Redi-Spine™ instruments in a compact, elegant kit,” explained Jon Rinehart, chief financial officer of Innovative Surgical Designs. “When we first started heading down the path of polymer instruments, I candidly admit that I was skeptical. I didn’t think an injection-molded alternative to stainless steel was possible. But when we started working with Solvay’s Ixef® PARA resin, I realized how wrong I was. We wouldn’t be able to offer the Redi-Spine™ kit for all of our surgeons’ one- and two-level cases without Solvay’s high-performance polymer and application support.”
Designed to withstand the severe torsional forces and rigors of thoracolumbar spinal fixation, Innovative Surgical Designs’ Redi-Spine™ instruments received 510(k) clearance from the U.S. Food & Drug Administration (FDA) in August. It contains multiple disposable, handheld instruments including a T-ratchet handle, counter-torque tool and gearshift probe that are molded entirely or in part from Solvay’s Ixef® GS-1022 PARA.
Ixef® GS-1022 PARA can be sterilized with gamma ray radiation without any significant change to its mechanical properties, ultra-smooth finish or color. Solvay offers the material in a range of gamma-stabilized colors, from which Innovative Surgical Designs, Inc. chose gray for its kit. Solvay’s polymer has also been evaluated for ISO 10993 limited duration biocompatibility and is supported by an FDA Master Access File, which can help streamline regulatory approvals.
“The growing adoption of single-use surgical instruments has increasingly established Solvay’s Ixef® PARA as a mainstream material for these applications,” said Jeff Hrivnak, business manager for Healthcare at Solvay’s Specialty Polymers Global Business Unit. “We continue to build on our early and proactive support of this trend by working closely with trailblazers like Innovative Surgical Designs, Inc. to help optimize their products for molding and speed to market.”
Innovative Surgical Designs plans to launch the Redi-Spine™ kit during the fourth quarter of 2018. For more related news about specialty polymers for healthcare, please go to www.solvayhealthcarenews.com.
® Ixef is a registered trademark of Solvay
™ Redi-Spine is a trademark of Innovative Surgical Designs
Innovative Surgical Designs Inc. is a privately held, orthopedic medical device company focused on developing breakthrough minimally invasive spinal solutions for patients. The company intends to achieve improved patient outcomes while lowering costs throughout the clinical value chain. If you are interested in learning more about our products, please go to www.innovativesurgicaldesigns.com.
Solvay is an advanced materials and specialty chemicals company, committed to developing chemistry that addresses key societal challenges. Solvay innovates and partners with customers worldwide in many diverse end markets. Its products are used in planes, cars, batteries, smart and medical devices, as well as in mineral and oil and gas extraction, enhancing efficiency and sustainability. Its lightweighting materials promote cleaner mobility, its formulations optimize the use of resources and its performance chemicals improve air and water quality. Solvay is headquartered in Brussels with around 26,800 employees in 61 countries. Net sales were €10.1 billion in 2017, with 90% from activities where Solvay ranks among the world’s top 3 leaders, resulting in an EBITDA margin of 22%. Solvay SA (SOLB.BE) is listed on Euronext Brussels and Paris (Bloomberg: SOLB.BB - Reuters: SOLB.BR) and in the United States its shares (SOLVY) are traded through a level-1 ADR program. Financial figures take into account the announced divestment of Polyamides.
Solvay Specialty Polymers manufactures over 1500 products across 35 brands of high-performance polymers – fluoropolymers, fluoroelastomers, fluorinated fluids, semi-aromatic polyamides, sulfone polymers, ultra-high performance aromatic polymers, and high-barrier polymers – for use in Aerospace, Alternative Energy, Automotive, Healthcare, Membranes, Oil and Gas, Packaging, Plumbing, Semiconductors, Wire & Cable, and other industries. Learn more at www.solvayspecialtypolymers.com.