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Alpharetta, Ga., May 2, 2018 --- Solvay, a leading global supplier of specialty polymers, announced today that its biocompatible Radel® polyphenylsulfone (PPSU) was the material of choice for key components of the surgical instrumentation for BioStable Science & Engineering’s HAART 300 Aortic Annuloplasty Device, the first internal annuloplasty device designed specifically for aortic valve repair.
“Development of reusable cardiothoracic surgical instruments demands the use of proven material solutions from recognized industry suppliers,” said John Wheeler, president & CEO of BioStable. “Radel® PPSU’s well-established record of success in healthcare and medical device applications made it an obvious choice for the kit’s sizer components, and Solvay’s industry-leading reputation for technical and regulatory expertise only improved confidence in our choice of material.”
Aortic insufficiency is a condition in which blood flows backwards into the heart because distortion of the three dimensional shape of the aortic valve prevents the valve leaflets from closing properly. BioStable’s HAART 300 device enables surgeons to reshape and stabilize the aortic valve base to help restore normal valve function and avoid valve replacement.
Machined from extruded Radel® R-5500 rod stock, the kit’s polymer sizers allow surgeons to quickly measure the dimension of a patient’s aortic valve leaflets and select the correctly sized HAART 300 Aortic Annuloplasty Device to properly close the valve.
“The sizers in the HAART 300 kit are a simple, yet elegant solution to provide surgeons with fast, accurate and reliable measurements during a highly sensitive procedure,” said Jeff Hrivnak, business manager for Healthcare at Solvay’s Specialty Polymers global business unit. “Solvay offered BioStable a similarly elegant solution in the form of Radel® PPSU – a tough, biocompatible polymer able to withstand repeated sterilization cycles and capable of supporting molding or machining processes with equal proficiency.”
The thermal stability, chemical resistance and excellent hydrolytic stability of Radel® PPSU make it an excellent choice for medical devices requiring repeated disinfection and steam sterilization. Parts made from the material can withstand over 1,000 autoclave cycles without significant loss of mechanical properties.
BioStable’s HAART 300 Aortic Annuloplasty Device surgical kit is commercially available in the U.S. and Europe.
® Radel is a registered trademark of Solvay
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 & Gas, Packaging, Plumbing, Semiconductors, Wire & Cable, and other industries.
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.
