— Press Release —
Redlands, CA / Austin, TX (February 14, 2013) – Renovis Surgical Technologies, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the A200 Cruciate Retaining Total Knee System. This new knee system was designed for anatomic fit and long-term performance and includes the advanced bearing option, Renovis E-MAX™ Highly Crosslinked Polyethylene.
Renovis E-MAX Highly Crosslinked Polyethylene is a proprietary material that is mechanically annealed and vitamin E blended to achieve ultra-low wear, improved mechanical properties over traditional highly crosslinked materials, and antioxidant protection. The base technology was originally developed by polymer scientists at Massachusetts General Hospital (MGH) and Cambridge Polymer Group (CPG), both of Boston, Massachusetts. Renovis engineers fine-tuned the manufacturing parameters for full scale production and to meet the design requirements of the Renovis Total Knee System.
Oxidation is well-known as a leading cause of polyethylene degradation. Researchers have shown that the joint fluid contains potential oxidizers that can be absorbed by the polyethylene over time in vivo, triggering oxidation. Vitamin E, a natural antioxidant, is blended into the raw material of Renovis E-MAX. Once implanted, this vitamin E continuously combats the absorbed oxidizers, stabilizing the polyethylene against oxidation.
The E-MAX process includes mechanical annealing, rather than melt annealing, a process that effectively eliminates free radicals introduced during the crosslinking process whle preserving mechanical strength. This is a distinct advantage over traditional thermal annealing processes. Thomas Ross, Vice President of Product Development at Renovis, explains, “The crosslinking of polyethylene has proven very successful at reducing wear, but we were interested in incorporating this new technology to further improve the longevity of our knee implants. In the E-MAX process, we use mechanical deformation along with annealing below the peak melting temperature, rather than remelting, to eliminate free radicals. This process, results in improved mechanical properties over traditional highly crosslinked materials which are typically remelted. This is crucial in the knee joint where stresses can be concentrated and properties like fatigue strength are especially important.”
The Renovis A200 Cruciate Retaining Total Knee System includes comprehensive size and configuration options to address a range of patient anatomies and surgical situations. The system was designed for anatomic fit, and the high-flex articular surfaces were optimized to maximize the range of motion. Inserts are available in congruent and ultra-congruent options, while the tibial implant is available in CoCrMo stemmed and Ti6Al4V keeled configurations.
Dr. Paul Burton, an orthopedic surgeon in Redlands, California, said, “This knee system lets me provide my patients with the latest technology available in knee replacement and the durability they need to get back to their active lives with an implant that should last a very long time.”
About Renovis Surgical
Renovis Surgical Technologies was founded in 2009 with the express mission of creating the highest quality implants for orthopedics, spine and trauma, and delivering those implants to the healthcare marketplace at a value. The company is based in Redlands, California, and has engineering and manufacturing operations in Austin, Texas.
For additional information on the Company, please visit renovis-surgical.com.
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