The growth of the implantable devices market is also attracting the attention of major polymer producers. At K 2007, Solvay Advanced Polymers announced a new family of biomaterials called Solviva for use in implantable medical devices.
Zeniva PEEK (polyetheretherketone). One of the most chemically resistant plastics available, PEEK also exhibits high strength and stiffness along with excellent toughness and fatigue resistance.
Proniva SRP (self-reinforced polyphenylene). Described as the stiffest and strongest unreinforced thermoplastic available, SRP also offers exceptional chemical resistance and hardness.
Veriva PPSU (polyphenylsulfone). This polymer offers toughness combined with transparency and excellent chemical resistance.
Eviva PSU (polysulfone). PSU provides “practical” toughness in a strong, transparent polymer.
New production processes and significant testing was required to make these materials eligible for implants. These efforts included meeting the relevant aspects of the current Good Manufacturing Practice (GMP) guidelines of the Food & Drug Administration’s 21CFR Part 820 Quality Systems Requirements and ensuring manufacturing operations are in compliance with relevant aspects of the ISO 13485 Quality Management System for the manufacture of medical devices.
OEMs evaluating the new materials include Zimmer Medical, a leading orthopedic supplier based in Warsaw, IN. The market for knee implants alone is $5.2 billion annually and is growing at an 8 percent clip, estimates Zimmer Chief Financial Officer James T. Crines.