Conformis, Inc. Launches First Patient-Specific, Bicompartmental Knee Resurfacing System on the Market
Burlington, Mass.— August 4, 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 first and only patient-specific bicompartmental knee resurfacing implant on the market. The iDuo™ is the third in the line of minimally invasive, patient-specific implants Conformis has developed for the treatment of osteoarthritis of the knee, the most common reason for knee replacement surgery.
The iDuo is a bicompartmental resurfacing implant designed for patients whose arthritic damage is limited to either the medial or lateral compartment of the knee, in addition to the patellofemoral compartment. Approximately 30% to 50% of patients who receive a total knee replacement today exhibit symptoms of osteoarthritis in just one or two of the three compartments of the knee.
The iDuo resurfaces only the affected areas, preserving far more bone on both the femur and tibia than traditional knee replacement surgery. The iDuo also preserves both the anterior and posterior cruciate ligaments, helping to maintain natural knee kinematics. The extent of tissue preservation with the iDuo helps patients retain their future surgical options. The implant is 510(k) cleared for marketing by the US Food and Drug Administration.
“The iDuo significantly advances the range of treatment options for patients who suffer from knee osteoarthritis. Traditionally, a patient with bicompartmental disease had a total knee as the only option. The iDuo provides a less invasive alternative for young and active patients that maintains their ability to move to a total knee in the future, if necessary,” said Dr. Philipp Lang, Chief Executive Officer and Chairman of Conformis.
Each iDuo is designed from an individual patient’s CT scan using the company’s proprietary iFit™ technology and made specifically for that patient. Because it is patient-specific, the iDuo allows for individualized fit, including full coverage of the tibial cortical rim, and a simplified surgical technique.
“The move toward patient-specific approaches enables the possibility of a minimally invasive, bone preserving, resurfacing procedure that allow patients to avoid a traditional total knee replacement, particularly if they are young and active.” said Dr. Tom Minas, Director of the Cartilage Repair Center at Brigham and Women’s Hospital in Boston and part of the surgeon design team for the iDuo. “As a surgeon, though, what has been especially intriguing for me is how much this approach has simplified and improved the surgical technique that can be employed for partial knee procedures.”
The iDuo 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. One tray of disposable iJigs replace multiple trays of traditional instrumentation that would typically have cost a hospital several hundred dollars per surgery in instrument handling, storage, sterilization and lost operating room time.
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.
Conformis, Inc. Announces Strong Clinical Study Results for Its Personalized Knee Implants
A retrospective review of 540 procedures performed demonstrated 98.5% Implant Survivorship and 89.0% Patient Satisfaction for the Conformis patient-specific iTotal®
Conformis, Inc. Announces 510(k) Clearance for Identity Imprint™ Knee Replacement System
Leveraging Conformis’ extensive library of personalized knee design data and patient images, Identity Imprint is designed to match patients’ anatomy
Clinical Study: Patient-Specific Total Knee Replacement with Conformis Technology Is More Cost-Effective Than with Leading Off-the-Shelf Implants
Independent, retrospective review of 2016-2019 surgeon data by University of Washington researchers demonstrates that Conformis iTotal® knee replacement implants enable