ConforMIS reports first iTotal surgeries
ConforMIS (Burlington, Massachusetts) reported the first surgeries using the iTotal CR knee resurfacing system were completed in Boston, Indio, California, and Houston this May. The iTotal builds on ConforMIS' patented iFit technology for generating individualized implants and instruments for each patient based on their own imaging data. The surgeries represent the first implantations of the only FDA cleared personalized total knee system on the market, ConforMIS said.
The patient-specific process for the iTotal CR produces customized implants with unique advantages. Each iTotal CR is made to fit an individual patient precisely without the sizing compromises common with traditional systems. The ability to maximize coverage for each patient enables one of the broadest implant contact areas in the industry, resulting in extremely low polyethylene contact stress.
In addition, patient-specific technology on the femur creates articulating surfaces that better mimic a patient's natural shape while preserving significantly more bone than a traditional total knee replacement. ConforMIS knee implants and instrumentation are designed to address all stages of osteoarthritis, the most common reason for knee replacement surgery.
InSite launches new AzaSuite Plus website
InSite Vision (Alameda, California) has established a new website for AzaSite Plus (www.AzaSitePlus.com), a late-stage product candidate currently in development for the potential treatment of blepharitis. The website provides a central location for all clinical and regulatory updates and will be a useful source of information for the public, interested patients suffering from blepharitis and potential commercial partners.
InSite recently received a special protocol assessment (SPA) from the FDA for the design of the company's phase III DOUBle (Dual Ophthalmic agents Used in Blepharitis) clinical trial, which is simultaneously evaluating two of InSite's ophthalmic therapeutics, AzaSite Plus and DexaSite in patients with blepharitis.
InSite Vision makes ophthalmologic products for unmet eye care needs.