ConforMIS Introduces the First Patient-Specific Unicompartmental Knee Resurfacing Implant on the Market
Ground-breaking Partial Knee Implant and Instrumentation Now Available
Burlington, Mass. – February 25, 2008 – ConforMIS, Inc., a privately held orthopedics company that develops and commercializes minimally invasive medical devices for the treatment of osteoarthritis and joint damage, today announced the launch of the iUni™ unicompartmental knee resurfacing implant and its accompanying iJig™ disposable instrumentation. The iUni is one of four patient-specific implants ConforMIS has developed for the treatment of osteoarthritis of the knee, the most common reason for knee replacement surgery.
The iUni is a unicompartmental resurfacing implant designed for patients whose arthritic damage is isolated to either the medial or lateral compartments of the knee, with little to no damage present in the other compartments. The use of a unicompartmental implant is often referred to as “partial knee replacement.” The implant is available for either the medial or lateral compartments and is 510(k) cleared for marketing by the US Food and Drug Administration and CE Marked for sale in Europe .
“The launch of the iUni represents an important milestone in ConforMIS’ commitment to advancing the state-of-the-art in orthopedics with our patient-specific, minimally traumatic knee implants,” said Dr. Philipp Lang, Chief Executive Officer and Chairman of ConforMIS. “Our image-to-implant technology offers physicians a unique, bone preserving option for early intervention combined with a simplified and reproducible surgical technique. We believe the advantages of our patient-specific approach will continue to increase adoption of ConforMIS implants within the orthopedics community.”
As with all ConforMIS implants, each iUni is designed from an individual patient’s imaging study, in this case a CT scan, using the company’s proprietary iFit™ technology and made specifically for that patient. Because it is patient-specific, the iUni allows for true resurfacing of the femur and complete coverage of the weight bearing surfaces for each patient, a result not previously achievable with off-the-shelf implants. Complete cortical rim coverage on the tibia, for example, is expected to reduce the risk of implant subsidence and loosening, key failure mechanisms for standard unicompartmental replacements.
“Being able to utilize imaging data to develop patient-specific knee implants provides a significant advantage over existing traditional knee replacement techniques,” said Dr. Wolfgang Fitz of Brigham and Women’s Hospital in Boston , a member of the faculty at Harvard Medical School and part of the surgeon design team for the iUni. “The ability to take advantage of this technology for new and unique implant designs and improved surgical techniques should expand both the patients and surgeons who can successfully utilize a partial knee resurfacing product.”
The iUni comes packaged together with patient-specific instrumentation called iJigs, which are designed from the same scans as the implant, including data on the patient’s biomechanical axis. The iJig cutting and placement guides eliminate manual sizing during surgery and provide tactile guidance to precisely place the instruments, simplifying the surgical technique. The disposable iJigs replace multiple trays of traditional instrumentation and save the hospital hundreds of dollars in instrument handling, storage, and sterilization costs.
About ConforMIS, Inc.
ConforMIS, Inc. is a privately held company that develops and commercializes medical devices for the treatment of osteoarthritis and joint damages. The Company’s novel and scaleable ‘image-to-implant’ process is comprised of two related technology platforms. iFit™ Technology enables the creation of conforming, patient-specific implants that are precisely sized and shaped to match the 3D topography of the patient’s anatomy. iJig™ Instrumentation enables the creation of disposable, easy-to-use instrumentation that simplifies the surgical process and improves reproducibility.
Both platforms are supported by proprietary, intellectual property consisting of more than 120 patents and pending patent applications that span imaging software, image processing, implant design, surgical techniques and instrumentation.
To date, ConforMIS has developed a comprehensive line of minimally traumatic, bone and cartilage-preserving knee implants and instrumentation designed to address all stages of osteoarthritis. Each of these devices has been cleared by the US Food and Drug Administration for marketing in the U.S.