BURLINGTON, Mass.--(BUSINESS WIRE)--ConforMIS, Inc. today announced the commercial availability of its iTotal® G2 Knee Replacement System, the only patient-specific total knee replacement (TKR) available on the market today. The iTotal G2 is the next generation version of the iTotal which was FDA cleared in January 2011 and launched into limited surgeon release in May 2011. The iTotal G2 incorporates improvements, based on a year’s worth of surgeon feedback, to the implants, instrumentation and patient specific planning guides.
Studies have shown that 1 in 5 patients with a total knee replacement system are not satisfied with the results of their surgery.i Issues such as implant overhang, errors in component placement and off-the-shelf implant shapes that do not match the patient’s native anatomy can result in residual pain,ii-iii functional limitationsiv and a knee that does not feel natural.iv By preserving the core benefits of the iTotal TKR system, including an anatomic implant design with personalized fit, a patient-matched anatomic shape and greater bone preservation than traditional total knee replacements,v the iTotal G2 is designed to address the drivers of patient dissatisfaction.
“The iTotal G2 is the most advanced and innovative knee system that ConforMIS has introduced,” said Philipp Lang, MD, CEO of ConforMIS. “Our technology preserves more of a patient’s natural anatomy and their individual shape than is possible with off-the-shelf systems. The fact that the implants are personalized, not just the instruments, is what provides the iTotal G2 with clinical advantages that other systems will not be able to replicate.”
The iTotal G2 was developed on the foundation of the company’s patented iFit® technology for designing patient-specific implants and jigs. Each iTotal G2 is made to fit an individual patient precisely based on their CT scan. Since each implant is made to fit just one patient, surgeons avoid the sizing and fit trade-offs that are a traditional part of standard knee surgery. The implant shape and geometry also closely matches the patient’s natural joint anatomy and curvatures, providing the potential for more natural knee motion. Finally, the pre-navigated disposable instruments help place the implants accurately and reproducibly.
“For the patient population that requires a total knee replacement, the physician’s ultimate goal is to give patients a long lasting, more natural feeling knee,” said Dr. Gregory Martin, medical director of the Orthopedic Institute at JFK Medical Center in Florida and a member of the surgeon design team for the iTotal G2. “With the ConforMIS iTotal Knee System, I'm seeing in my early patient data that I’m resecting less bone, measuring less blood loss and that patients are having a quicker return to activities they enjoy. The patient response is noticeably different than what I’m used to seeing in my standard total knee patients.”
The iTotal G2 system comes packaged in a small sterile kit that includes the implant components and all of the disposable instruments for the procedure. In contrast to an off-the-shelf total knee system which may require between six to eight trays of instrumentation, only one reusable instrument tray is required at the hospital for the iTotal G2. This provides a highly efficient system that reduces the hospital inventory management, transport and sterilization costs. It also reduces the instrument set up and reprocessing required in the operating room.
As the iTotal G2 is introduced into broad commercial release, the company has updated the implant design to address a greater range of anatomies, introduced a more efficient and simplified surgical technique and instrumentation system, and updated the patient-specific iView® with more detailed surgical planning information.
For more information on ConforMIS visit www.conformis.com.
About ConforMIS, Inc.
ConforMIS, Inc. is a privately-held company that develops and commercializes medical devices for osteoarthritis treatment and joint damage. Its proprietary intellectual property includes more than 350 patents and patent applications in the areas of imaging software, image processing, implant design, surgical techniques, instrumentation, and manufacturing, spanning knee, hip, shoulder, spine, and small joints. ConforMIS knee implants and instrumentation are designed to address all stages of osteoarthritis, the most common reason for knee replacement surgery. All devices have been cleared by the US Food and Drug Administration for marketing in the US. In 2009, ConforMIS was named a winner of the Medical Design Excellence Awards for its iUni and iDuo resurfacing implants. In 2011, ConforMIS received a Medical Design Excellence Award and an American Technology Award for Innovation for the iTotal. Follow ConforMIS on Twitter at @ConforMIS and become a fan on Facebook.
i Bourne, R.B., et al; Patient Satisfaction after Total Knee
Arthroplasty. Who is Satisfied and who is not? Clinical Orthopaedics and
Related Research: 2010
ii Berger, et al; Malrotation Causing Patellofemoral Complications after Total Knee Arthroplasty. Clinical Orthopaedics and Related Research; 1998, 356: 144-153
iii Mahoney, et al; Overhang of the Femoral Component in Total Knee Arthroplasty: Risk Factors and Clinical Consequences. The Journal of Bone and Joint Surgery; 2010, 92: 1115-1121
iv Noble PC, et al. The John Insall Award: Patient Expectations Affect Satisfaction with Total Knee Arthroplasty. Clin Orthop Relat Res (2006) 452: 35–43
v Parsley, et al. Optimizing Knee Femoral Component Strength and Bone Preservation with Finite Element Analysis, ORS Poster 2012