— Press Release —
Redlands, CA / Austin, TX (June 13, 2012) – 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 A450 Acetabular Cup and A400 Tapered Cementless Hip Stem. This new line of hip replacement implants includes versatile femoral and acetabular offerings, including advanced bearing options such as Renovis E-MAX™ Highly Crosslinked Polyethylene with Vitamin E and BIOLOX® delta ceramic femoral heads.
Renovis E-MAX Highly Crosslinked Polyethylene is an advanced bearing material that was designed for ultra-low wear and contains vitamin E for 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 design requirements of Renovis hip components.
In orthopedic implant polyethylene, oxidation is well-known as the 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, to eliminate free radicals introduced during the crosslinking process. Thomas Ross, Vice President of Product Development at Renovis, explains, “Crosslinking polyethylene has been very successful at reducing wear, but this new technology offers further improvement. By using mechanical deformation along with annealing below the peak melting temperature to quench free radicals, rather than remelting, we were able to improve mechanical properties over traditional high crosslinked materials which are typically remelted. Our lab studies also showed that blending vitamin E into the polyethylene actively protects it from oxidation.”
The Renovis A400 Tapered Cementless Hip Stem is based on a proven design concept with over 25 years of excellent long-term clinical results. The proximal-loading, bone-conserving design with titanium plasma-spray coating is the gold standard in cementless hip replacement.
Dr. Tom Eickmann, an orthopedic surgeon in Denver, Colorado, said, “The Renovis Surgical Hip System has been an excellent solution for hip arthritis in my practice. The oxidative resistance and wear properties are impressive while the material properties are considerably better than previous generations of Vitamin E polyethylene.”
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. BIOLOX® is a registered trademark of Cerasiv GmbH Innovatives Keramick-Engineering and CeramTec AG Innovative Ceramic Engineering.
For additional information on the Company, please visit renovis-surgical.com.
# # #
Media Contact: 909.557.2360