Radel PPSU from Solvay applied to BioStable Annuloplasty device
Solvay has said 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.
John Wheeler, President and CEO of BioStable, said: “Development of reusable cardiothoracic surgical instruments demands the use of proven material solutions from recognised industry suppliers.
“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 stabilise 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.
Jeff Hrivnak, business manager for Healthcare at Solvay’s Specialty Polymers, said: “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. Solvay offered BioStable a similarly elegant solution in the form of Radel PPSU – a tough, biocompatible polymer able to withstand repeated sterilisation cycles and capable of supporting moulding 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 sterilisation. Parts made from the material can withstand over 1,000 autoclave cycles without significant loss of mechanical properties.