Unlike traditional total knee replacement which replaces the entire joint, ConforMIS said its partial knee resurfacing device allows for the targeted and minimally invasive treatment of just the diseased area of the knee in properly indicated patients.
In addition to a more targeted treatment approach, the iUni G2 uses advanced computer modeling and the latest manufacturing technology to provide an individually designed and manufactured implant for each patient.
The personalized shape and fit allows for greater bone and tissue preservation and the potential for more natural knee motion, in addition to a faster recovery than traditional total knee replacement.
The post-market trial involves patient screening and assessment to determine eligibility, a surgical procedure to implant the device, follow-up visits at the clinic, and long-term monitoring to gather information on the function and durability of pain relief from the iUni G2 implant.
STAR Orthopaedics clinical trial principal investigator Raj Sinha said they are eager to offer trial patients suffering from osteoarthritis this truly personalized solution and hopeful that the trial will provide them with more long-term insight into the benefits this approach delivers to patients.
ConforMIS is a privately-held company that develops and commercializes medical devices for osteoarthritis treatment and joint damage.
