03 Mar Conformis, Inc. Announces Clearance in Australia for iTotal® PS, the Only Personalized, Posterior-Stabilized Total Knee Replacement System
The iTotal® PS total knee replacement system is designed so that its patient-specific implants fit the unique size and shape of each patient’s knee, and provide optimal stability throughout the full range of motion.
BILLERICA, Mass., March 01, 2021 (GLOBE NEWSWIRE) — Conformis, Inc. (NASDAQ: CFMS) today announced the clearance of its patient-specific iTotal® PS total knee replacement system by the Therapeutic Goods Administration, which is part of the Australian Department of Health, and which authorizes the marketing of medical devices and other healthcare products in Australia.
The iTotal® PS system, which launched in the United States in 2016, is designed to address the shortcomings of traditional, off-the-shelf knee replacements that are manufactured in limited sizes and shapes. iTotal® PS implants are specifically designed to restore the natural shape of each patient’s knee, and to avoid overhang, rotation, and sizing compromises associated with pain after surgery. 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). iTotal® PS implants use a customized cam and spine feature to serve the function of the posterior cruciate ligament and to provide optimal stability throughout the full range of motion.
“Receiving clearance for our iTotal® PS product in Australia will allow us to offer a best-in-class, patient-specific solution to relieve patients’ chronic knee joint pain,” said Mark Augusti, President and CEO. “With this clearance, we have greatly expanded the number of potential patients who will be candidates for our personalized knee replacement implants, and we are thrilled to offer the benefits of our unique technology to surgeons in Australia who prefer a posterior-stabilized design to a cruciate-retaining one.”
iTotal® PS is designed with the following features and benefits:
- patient-specific femoral and tibial fit to avoid overhang, under-coverage, and sizing compromises;
- patient-specific shape designed to provide stability throughout the range of motion and to restore kinematics;
- patient-specific cam and spine to provide optimal stability and to reduce the potential for a “mechanical” feel;
- pre-operative surgical plan to enable a predictable, reproducible knee replacement procedure; and
- a safe and simple delivery model that includes a single pre-sterilized kit, a single reusable instrument tray, and no implant inventory.
The global knee joint reconstruction market is projected at more than $9 billion. HCF, Australia’s largest nonprofit health insurer, reports that more than 50,000 knee replacement procedures are performed in Australia each year.
About Conformis, Inc.
Conformis is a medical technology company that uses its proprietary iFit® Image-to-Implant® technology platform to develop, manufacture, and sell joint replacement implants and instruments that are individually sized and shaped, which it refers to as personalized, individualized, or sometimes as customized, to fit and conform to each patient’s unique anatomy. Conformis offers a broad line of sterile, personalized knee and hip implants and single-use instruments delivered to hospitals and ambulatory surgical centers. In clinical studies, the Conformis iTotal® CR knee replacement system demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. Conformis owns or exclusively in-licenses issued patents and pending patent applications that cover personalized implants and patient-specific instrumentation for all major joints.
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