BEDFORD, Mass.--(BUSINESS WIRE)--ConforMIS, Inc., a medical device company pioneering patient-specific orthopedic implants, today announced results from several clinical research studies highlighting the benefits of the iTotal® customized total knee replacement. Results were shown this week at the British Association for Surgery of the Knee (BASK) meeting in Norwich, UK.
The iTotal system, the only customized total knee replacement system on the market, demonstrated zero blood transfusions and positive clinical outcomes. A recent Cleveland Clinic study reported a 12% rate of blood transfusions for traditional, off-the-shelf knee replacements. These transfusions were associated with increased costs of over $2,200 per incident, longer hospital stays and a higher incidence of complications.1 In a review of 106 iTotal replacements, including 15 simultaneous bilateral replacements, there were no blood transfusions required.
Even more important, 100% of patients reported a normal feeling knee only seven months after the procedure. This is in contrast to high dissatisfaction rates reported in the literature, ranging from 15% to 39% of knee replacement patients with standard, off-the-shelf implants.2,3
“We are very pleased to see further clinical evidence showing that the ConforMIS patient-specific technology is not only helping surgeons to improve patient outcomes with knee replacements, but the technology is also contributing meaningful cost savings to the healthcare system,” said Philipp Lang, M.D., Chairman and CEO of ConforMIS. “We believe that by providing a customized implant, patients will recover faster, quickly return to normal, everyday activities and ultimately forget they even had a knee replacement.”
ConforMIS clinical results presented at BASK include:
- “Early Outcomes Utilizing a First-Generation Customized Patient-Specific TKA Implant” (P0185). Lead researcher William Kurtz, M.D. shared the clinical results of patients implanted with the first-generation customized iTotal implant. In a population of 89 patients and 106 knees treated, no patients required blood transfusions and mean pre-op range of motion (ROM) was regained within an average of four months. No patients reported any dissatisfaction in four of five Knee Scoring System (KSS) categories, including pain while sitting and function while performing recreational activities. Unprecedented to any published reports on standard, off-the-shelf implants, all patients receiving iTotal reported a “normal” feeling knee seven months after the procedure.
- “Intraoperative Assessment of Mechanical Alignment Accuracy Determined by Computer Navigation in a Patient-Specific TKA (Total Knee Arthroplasty) System” (Session 6). Data presented by Gary A. Levengood, M.D. demonstrated that in a population of 63 patients treated with iTotal, 100% achieved alignment within ± 2° of the neutral mechanical axis. Restoration of alignment within 3° of neutral is a widely confirmed indicator of improved long-term survivorship in TKA.
- “In Vivo Tibial Fit Analysis of Customized, Patient-Specific TKA Versus Off-the-Shelf TKA” (P0181). Data demonstrated that use of iTotal significantly improves tibial fit when compared to off-the-shelf TKA implants. The study concluded, “this could play an important role in reducing knee pain and patient dissatisfaction … as well as implant loosening.”
About ConforMIS, Inc.
ConforMIS, Inc. is a privately-held medical device company that is pioneering a patient-specific approach to orthopedic implants and instrumentation. Its proprietary technology is supported by more than 375 patents and patent applications. ConforMIS’ award winning partial and total knee replacement solutions, the iUni® G2, iDuo® G2 and iTotal® G2, are individually designed for each patient. Potential advantages compared to traditional off-the-shelf implants include faster recovery, shorter hospital stay, less blood loss, more bone preservation, and better functional outcomes with more natural feeling knees. ConforMIS products are provided in a pre-sterilized single package delivery system that can help hospitals reduce costs and treat more patients by reducing instrument re-sterilization costs and shortening set-up, procedure and turnover times. The iUni® G2, iDuo® G2 and iTotal® G2, have been cleared by the U.S. FDA and are CE Marked in Europe.
ConforMIS is the leader in additive manufacturing in the orthopedic and medical device space. ConforMIS is the only orthopedic company that offers Just-In-Time (JIT) manufacturing with a single-package delivery system, resulting in greatly enhanced use of working capital.
ConforMIS technology is broadly applicable to all joints. The company is expanding into new applications and indications.
1 Szubski, et al; National Trends in Utilization and Outcomes
of Allogenic Blood Transfusion in Primary Total Knee Arthroplasty,
2000-2009. ISTA Annual Meeting 2013. Poster #2451
2 Hawker, et al; Health-Related Quality of Life after Knee Replacement. Journal of Bone and Joint Surgery; 1998, 80-A #2: 163-173
3 Suda, et al; Are Patients’ Expectations of Hip and Knee Arthroplasty Fulfilled? A Prospective Study of 130 Patients. Orthopedics; 2010, 33 #2: 76-80