This recognition is in support of the company’s unique commitment to delivering orthopedic implants that precisely fit each individual unlike traditional implants that require surgeons to shape patients’ bones to fit standardized implants.
“The field of orthopedic implants is poised to transition towards personalized implants since off-the-shelf implant designs cannot accommodate all of the anatomic variations present across patients,” explains Frost & Sullivan Research Analyst Archana Swathy. “ConforMIS is a pioneer, fueling this transition through the company’s revolutionary technology platforms – the iFit™ technology and iJig™ instrumentation.”
While traditional orthopedic implants have undergone a long continuum of scaled developments to reach a certain level of sophistication, ConforMIS aims to revolutionize the very approach to implants through customization. Surgeries involving ConforMIS implants are minimally invasive, removing minimal bone and cartilage. This radical patient-specific initiative employs the proprietary “image-to-implant” technology platforms. The iFit technology transforms CT and MR imaging data into implants that are made to precisely fit the topography of the damaged joint. The same imaging data is utilized to create the iJig instrumentation, which are disposable patient-specific cutting and placement guides that help simplify the surgical process and improve surgical outcomes and efficiency.
The image-to-implant technology platforms ensure optimal implant fit and alignment, while offering complete coverage of weight-bearing surfaces. ConforMIS implants also offer thorough coverage of the cortical rim on the tibia, which minimizes the risk of subsidence and loosening, which are often observed with traditional implants.
Noteworthy milestones for ConforMIS have included FDA clearance for the iUni™ uni-compartmental resurfacing system and for the iDuo™ bi-compartmental resurfacing system. These patient-specific, partial knee resurfacing systems treat arthritic damage confined to one or two compartments of the knee. The iUni and the iDuo represent novel approaches to early intervention, using a personalized approach not previously available in orthopedics. The launch of these pioneering products demonstrate ConforMIS’s dedication to revolutionizing the joint-replacement industry. ConforMIS has one other product already in commercialization in the United States and Europe: the iForma™ knee interpositional device. The company plans to release the iTotal tri-compartmental knee resurfacing system in 2009.
Due to the simplicity of the surgical procedures, ConforMIS’s surgeon training utilizes an online model and allows for unusually rapid movement down the learning curve. ConforMIS also aims to conduct post-approval studies that can help evaluate and establish the long term efficacy of its products.
“ConforMIS has entered a new dimension in advancing the scope of orthopedic implants,” states Swathy. “Through the unique patient-specific approach, the company is able to target patients who benefit from early medical intervention and for whom a traditional total knee replacement would be too invasive.”
Addressing this distinctive patient pool with its novel technology creates an opportunity to expand the market for joint implants. The technology provides a less-invasive alternative that maintains options for other, future surgical treatments. It is this commitment to improving patients’ quality of life and helping surgeons serve patients more effectively that makes ConforMIS a deserving recipient of the 2008 Frost & Sullivan Medical Device Healthcare Innovation Award for personalized/customized care.
Each year, Frost & Sullivan presents this award to the company that has introduced truly innovative products, practices, or ideas to the specified industry or segment. The company's innovative contribution(s) to healthcare make it possible to envision a new level of care in the diagnosis, treatment, and management of disease, leading to better outcomes and quality-of-life for patients. In addition, the company's innovative efforts may also lead to improvements in the tools that clinicians, diagnosticians, researchers, and healthcare administrators have at their disposal to improve quality and efficiency in provision of healthcare services.
Frost & Sullivan Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research in order to identify best practices in the industry.
ConforMIS, Inc. (conformis.com) is a privately held company that develops and commercializes medical devices for the treatment of osteoarthritis and joint damages. The Company’s novel and scaleable 'image-to-implant' process is comprised of two related technology platforms. iFit™ Technology enables the creation of conforming, patient-specific implants that are precisely sized and shaped to match the 3D topography of the patient's anatomy. iJig™ Instrumentation enables the creation of disposable, easy-to-use instrumentation that simplifies the surgical process and improves reproducibility.
To date, ConforMIS has developed a comprehensive line of minimally traumatic, bone and cartilage-preserving knee implants and instrumentation designed to address all stages of osteoarthritis. Each of these devices has been cleared by the US Food and Drug Administration for marketing in the U.S.
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