BURLINGTON, Mass.–(BUSINESS WIRE)–ConforMIS today announced that the first surgeries using the iTotal® CR knee resurfacing system were successfully completed in Boston, Massachusetts, Indio, California, and Houston, Texas in May of 2011. The iTotal builds on ConforMIS’ patented iFit® technology for generating individualized implants and instruments for each patient based on their own imaging data. The surgeries represent the first implantations of the only FDA cleared personalized total knee system on the market.
“We will expand the launch to select surgeons in the US and Europe, with the goal of broad commercialization next year.”
“After years of R&D investment in getting to this point, we are extremely pleased with the feedback from the first iTotal CR knee resurfacing system surgeries,” said John Slamin, Senior Vice President of Engineering at ConforMIS. “In my over 35 year career in knee replacement, I’ve been involved with many advances in knee replacement surgery. These first iTotal cases reinforce my belief that patient-specific knee replacement will redefine the category.”
The patient-specific process for the iTotal CR produces customized implants with unique advantages. Each iTotal CR is made to fit an individual patient precisely without the sizing compromises common with traditional systems. The ability to maximize coverage for each patient enables one of the broadest implant contact areas in the industry, resulting in extremely low polyethylene contact stress. In addition, patient-specific technology on the femur creates articulating surfaces that better mimic a patient’s natural shape while preserving significantly more bone than a traditional total knee replacement (TKR).
“The extremely positive feedback and experience with the initial iTotal surgeries and the recently announced CE Mark approval continues to strengthen our global momentum,” said Dr. Philipp Lang, MD, CEO of ConforMIS. “We will expand the launch to select surgeons in the US and Europe, with the goal of broad commercialization next year.”
ConforMIS has won wide recognition for patient-specific implant systems that conserve bone, preserve joint motion, streamline the surgical procedures and increase operating room efficiency. In 2010, ConforMIS launched the iUni® G2 and iDuo® G2 next-generation systems for partial knee disease, providing less invasive alternatives to TKR for patients suffering from partial knee osteoarthritis.
For more information on ConforMIS visit www.conformis.com.
About ConforMIS, Inc.
ConforMIS, Inc. is a privately-held company that develops and commercializes medical devices for osteoarthritis treatment and joint damage. Its proprietary intellectual property includes more than 250 patents and patent applications in the areas of imaging software, image processing, implant design, surgical techniques, instrumentation, and manufacturing, spanning knee, hip, shoulder, spine, and small joints. ConforMIS knee implants and instrumentation are designed to address all stages of osteoarthritis, the most common reason for knee replacement surgery. All devices have been cleared by the US Food and Drug Administration for marketing in the US and CE Marked in Europe. In 2009, ConforMIS was named a winner of the Medical Design Excellence Awards, the premier recognition for contributions and advances in the design of medical products, for its iUni and iDuo resurfacing implants. Follow ConforMIS on Twitter at @ConforMIS and become a fan on Facebook at www.facebook.com/ConforMIS.