AAOS News: Customized Posterior-Stabilized Knee Replacement System Launched

ConforMIS Inc., a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture, and sell joint replacement implants that are customized to fit each patient’s unique anatomy, has announced the full commercial launch of iTotal PS, the only customized posterior stabilized knee replacement system. Over 1,000 patients have been treated by select orthopedic surgeons using the iTotal PS during the limited launch over the past twelve months. The full commercial launch took place at the American Academy of Orthopaedic Surgeons meeting in Orlando, Fla. from March 1-5, 2016.
 
Recent studies have demonstrated that approximately twenty percent or more of patients who receive an off-the-shelf total knee replacement are not satisfied with the results. The ConforMIS iTotal PS was designed to address the shortcomings of traditional knee replacements, which come in a fixed set of sizes and shapes. The customized iTotal PS implant builds on the advantages of the iTotal CR system, first introduced in May 2011. The iTotal PS implants are customized for each patient to avoid overhang, rotation, and sizing compromises, common causes of pain after surgery. In addition, iTotal PS is designed to restore the natural shape of each patient’s knee and has a customized cam and spine to provide optimal stability throughout the full range of motion.
 
Primary total knee implants are designed to either retain the patient’s own posterior cruciate ligament (cruciate retaining, or CR), or substitute for it (posterior stabilized, or PS). PS implants use a cam and spine feature to serve the function of the posterior cruciate ligament. The choice between CR and PS is largely based on surgeon preference. However, PS is heavily preferred in the US market, representing approximately 72 percent by revenue of all primary total knee replacements. With the launch of iTotal PS, combined with its existing iTotal CR, iDuo and iUni products, ConforMIS can address a much greater population of patients.
 
“The goal of a total knee replacement is a predictable outcome and a happy patient, every time. With off-the-shelf implants, most of the time we must make compromises,” said Jose A. Rodriguez, M.D., chief of reconstruction arthroplasty and the director of the Arthroplasty Fellowship Program at Lenox Hill Hospital in New York City. “With ConforMIS, many of these compromises are eliminated because the implant fits anatomically. The reliability with which I can achieve a knee that fits better, and functions more naturally for my patients, is greater with iTotal PS than with standard, off-the-shelf implants.”
 
“The full launch of the iTotal PS nearly triples our addressable market. We believe this launch is our single biggest commercial opportunity to date,” said Philipp Lang, M.D., M.B.A., chief executive officer and president of ConforMIS. “With iTotal PS, we have now greatly expanded the number of patients who will be candidates for our customized knee replacement implants. We are very excited to bring the benefits of customized knee replacements to surgeons who prefer a posterior-stabilized design. Since we initiated our limited launch of iTotal PS last year, the feedback from surgeons has been extremely positive.”
 
The ConforMIS customized knee replacement products offer significant benefits to hospitals with a unique just-in-time delivery model. This model includes a single, pre-sterilized kit of patient-specific instruments, a single reusable instrument tray, and no implant inventory. The ConforMIS iTotal CR has already demonstrated clinical and economic benefits for surgeons, patients, and hospitals for an entire episode of care, from the initial hospitalization through recovery. We believe that promoting such clinical and economic benefits is critical to bundled payment programs such as the new Medicare Comprehensive Care for Joint Replacement.