Vertera Spine, a developer of medical devices with advanced functional surface technologies for spine applications, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its COHERE™ Cervical Interbody Fusion Device. COHERE features Vertera Spine's novel PEEK Scoria™ biomaterial, a proprietary porous surface technology that is based on Zeniva® PEEK resin from Solvay Specialty Polymers. While PEEK implants with porous or rough metal coatings have found their way into clinical use, COHERE is the first FDA cleared spine device to be manufactured entirely out of PEEK and contain porosity. Both Vertera Spine and Solvay will be showcasing COHERE and PEEK Scoria at Solvay's booth (#1483) at the upcoming North American Spine Society Meeting in Chicago from October 14-17, 2015.
PEEK Scoria was developed to address the clinical need for fusion devices that better osseointegrate while still remaining cost-effective. Backed by extensive research at Duke University and the Parker H. Petit Institute for Bioengineering and Bioscience at Georgia Institute of Technology, Scoria represents a breakthrough in how surface technologies are applied to medical devices. Unlike surface treatments that are coated onto the device, Scoria is grown directly out of the solid PEEK Zeniva material, creating a seamless surface-to-solid material interface that is more durable than metal coatings and two times stronger under shear loading than trabecular bone.1 In addition because Scoria can be fabricated onto the device without using any additive material, manufacturing costs are significantly lowered compared with metal-coated implants. This innovative process allows implants with this porous technology to be priced competitively with current PEEK device offerings and more cost effective than titanium-coated fusion devices.
"The FDA clearance of COHERE represents a significant milestone for Vertera Spine and fusion devices in spine," said Chris Lee, PhD, co-founder and CEO of Vertera Spine. "Given the new economics of healthcare, market demands are shifting towards more effective implant technologies at a better price. COHERE, featuring surface porous PEEK Scoria, will be the first in a new generation of biomedical implant innovations to meet this demand."
Studies in the literature report on the advantages of adding porosity to implant surfaces to form a more stable union with bone.2 At the previous two Spine Technology and Educational Group Organization meetings, Frank Phillips, MD, a founder and Past President of the Society for Minimally Invasive Spine Surgery and a member of the Vertera Spine Scientific Advisory Board, delivered a presentation highlighting these surface effects on implant integration. Designed to facilitate bone tissue in-growth, Scoria features a fully interconnected pore network with an 300um average pore size, over 500μm layer thickness, and wettable surface.3 Initial pre-clinical testing has demonstrated that bone is able to infiltrate the porous feature and form direct contact with the PEEK Scoria surface.1 These results, published in Acta Biomaterialia and also presented by Dr. Phillips, suggest that the Scoria technology could improve how PEEK devices interact with bone.
According to Dr. Phillips, "What convinced me of PEEK Scoria's clinical potential were the substantial results compiled from academic research showing that the Scoria surface can effectively osseointegrate with bone and does not have the potential to shear off like titanium coatings."
Developed in collaboration with a select team of surgeons, the COHERE Cervical Interbody Fusion Device leverages PEEK Scoria to combine the benefits of introducing a porous environment to bone without compromising the mechanical integrity of the implant. Since it is made entirely out of PEEK, COHERE also provides the additional advantage of not producing any medical imaging artifacts, allowing the surgeon to easily assess the fusion site. Vertera Spine will be launching COHERE in multiple footprint and height configurations in 2016.
"Surgeons have been seeking an all PEEK fusion solution that leads to direct bone apposition instead of fibrous encapsulation," said Tim Nash, Vertera Spine board director with over 20 years experience in the spine and orthopedics industries. "COHERE is a game-changing device for spine fusion. By leveraging the performance of the Scoria technology, Vertera Spine will be able to generate a portfolio of implant solutions that were previously not possible."
Solvay's Zeniva PEEK is part of the Solviva® Biomaterials line-up, which is offered for use in implantable medical devices. The biomaterial boasts a modulus very close to that of cortical bone plus excellent biocompatibility, toughness, and fatigue resistance.
SOURCE Vertera Spine