FDA approves first porous PEEK–based medical deviceFDA approves first porous PEEK–based medical device
This week, MedShape Inc. (Atlanta) received US FDA 510(k) clearance for its Morphix SP Suture Anchor, which features the company's new Scoria technology, a polyetheretherketone (PEEK) material manufactured with micrometer-scale surface porosity and based on Zeniva PEEK resin from Solvay Specialty Polymers (Atlanta). MedShape reportedly is the first company to develop and clear through FDA a device containing porous PEEK.
March 20, 2014
Although studies have shown the benefits of adding porosity to biomaterials to support tissue ingrowth around an implant, the use of porous polymers has been limited in orthopaedic load-bearing applications because of a loss in mechanical properties.
PEEK Scoria uses a proprietary processing method that seamlessly connects a porous surface to a solid base. This structure maintains a shear strength twice that of trabecular bone; the overall material has mechanical strength, stiffness, and fatigue resistance in line with solid PEEK and greater than some implantable porous metals. The Scoria surface features 65% porosity, a 300 micron average pore size, and 99% interconnectivity.
The material was developed at the Georgia Institute of Technology through a grant from Solvay.
Biomaterials expert Professor Bob Guldberg, director of the Parker H. Petit Institute for Bioengineering and Bioscience at Georgia Institute of Technology, has recently studied bony ingrowth in PEEK Scoria. The results of his work were presented this week at the Orthopaedic Research Society Annual Meeting in New Orleans. "The preliminary data demonstrate bony ingrowth into the porous PEEK Scoria network," Goldberg is quoted as saying in a press release published by Solvay. "Future studies will include a fundamental understanding of the extent of osseointegration and soft tissue attachment, and the impact of the release of biologic agents from the porous network."
"PEEK Scoria is an exciting new technology platform for MedShape that is backed by extensive university biomaterials research," adds Ken Gall, PhD, Professor of Mechanical Engineering and Materials Science at Georgia Institute of Technology and also Chief Technology Officer at MedShape. "Research is ongoing to create polymer devices capable of providing both immediate mechanical strength and local surface structure-mediated biological repair without the drawbacks of complete device resorption."
Solvay's Zeniva PEEK is part of the Solviva Biomaterials portfolio which is offered for use in implantable medical devices. The biomaterial boasts a modulus very close to that of bone plus excellent biocompatibility, toughness, and fatigue resistance, according to Solvay.
A video showing how the suture anchor works can be viewed on the MedShape website.
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