Advancements in Patient-Specific Knee Surgery Technique Reported in the June Issue of Orthopedics Today
Burlington, Mass. – June 11, 2008 – ConforMIS, Inc., a privately held company that develops and commercializes minimally invasive orthopedic devices, announced today that the iUni™ unicompartmental knee resurfacing implant and its accompanying iJig instrumentation are featured in the June issue of Orthopedics Today.
The article, “Uni-knee resurfacing with patient-specific implants and instrumentation,” was written by Wolfgang Fitz, MD, and Tom Minas, MD, MS, both of Brigham and Women’s Hospital in Boston, MA. Drs. Fitz and Minas described the surgical technique for a personalized knee implant that utilizes ConforMIS’ advanced imaging technology. The patient-specific nature of the implant and its disposable, single-use instrumentation provides for greater bone preservation and a much simpler surgical technique for the surgeon.
“We believe that ConforMIS’ technology can change the way the orthopedic industry views knee replacement surgery,” said Dr. Philipp Land, CEO of ConforMIS. “The advantages of a personalized implant make it an excellent option for early intervention patients and provide surgeons with a dramatically simpler surgical technique. Drs. Fitz and Minas do an excellent job of explaining how this is achieved in their article on customized knee 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 and an intact ACL. The iUni is one of four patient-specific implants ConforMIS has developed for the treatment of osteoarthritis, the most common reason for knee replacement surgery. 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.
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 patient’s weight bearing surfaces, a result not previously achievable with off-the-shelf implants.
“The advancements we have seen in personalized knee replacement surgery are extremely encouraging for both patients and surgeons,” said Dr. Wolfgang Fitz. “Our positive experience with the iUni is something we are trying to build on to give us an even more conservative option than traditional unicompartmental knee surgery.”
“Knee problems affect all types of patients,” said Dr. Tom Minas, MS, “The ability to address one or more compartments with a personalized resurfacing technology provides surgeons with ways to address patient issues that have not been available before.”
The iUni comes packaged together with patient-specific, disposable 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 image-based tactile guidance to precisely place the instruments, simplifying the surgical technique and potentially eliminating the need for computer guidance systems. The disposable iJigs replace multiple trays of traditional instrumentation and save the hospital the cost of instrument handling, storage, and sterilization.
About ConforMIS, Inc.
ConforMIS, Inc. is a privately held company incorporated in 2004 that develops and commercializes medical devices for the treatment of osteoarthritis and joint damages. The Company’s novel and scalable ‘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 anatomic bone surfaces. The iJig™ instrumentation enables the creation of novel disposable instrumentation that radically simplifies and improves the surgical process.
Both platforms are supported by proprietary, intellectual property consisting of more than 120 issued, allowed and pending patents or patent applications that span imaging software, imaging 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, the most common reason for knee replacement surgery. Each of these devices has been cleared by the US Food and Drug Administration for marketing in the U.S.