Hip Innovation Technology initiates FDA-approved investigational device exemption study

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The first U.S. implantation of the Reverse Hip Replacement system for Total Hip Arthroplasty has been completed

Hip Innovation Technology, LLC, a medical device manufacturer that develops innovative orthopaedic devices to improve the quality of patient care and the quality of their lives, has announced the first U.S. implantation under FDA-approved Investigational Device Exemptions (IDE) of the HIT® Reverse Hip Replacement System. The IDE Study will determine the safety and efficacy of the HIT reverse HRS for Primary Total Hip Arthroplasties (THA). Safety will be evaluated through the collection and analysis of adverse device events, as well as patient-reported quality of life metrics. The effectiveness of the device will be assessed using clinical, radiologic and patient-reported results.

Stephen Zabinski MD, Director of Orthopaedic Surgery at Shore Medical Center, Somers Point, New Jersey performed the first operation using this new exciting technology on 10 January 2023. Dr. Zabinski says, “The reverse hip system may offer unique benefits in terms of motion and stability.” My first patient, after doing research on the implant, had a strong desire to proceed. Her surgery was a success and I am excited to follow up with her and use Reverse HRS on additional patients.

George Diamantoni is the Co-Founder and CEO of Hip Innovation Technology. He said, “The ReverseHRS is a novel design for a hip implant that we believe represents a breakthrough technology and significant advancement for patients who require total hip arthroplasty.” We look forward to enrolling as many patients as possible in this clinical study, validating the potential clinical benefits, including hip stability over a wider range of motion, a reduced risk of dislocation of the device, and more latitude to place hip components compared to current designs.

Left: The components that make up a total hip implant. The implant is formed by combining the components. (Right) The hip implant.

In our ongoing Canadian Clinical Study, we have collected over five years’ worth of patient data using Radio-Stereometric Analysis. This data shows excellent fixation with aggregated data that suggests significant improvements from pre-to-post-operative measures for patients and physicians. Over 100 pre-clinical bench-level experiments have been conducted to assess the safety of the Reverse HRS and the clinical benefits that are anticipated.

The bench-level data compiled by the Reverse HRS exceeds all FDA requirements and sets the stage for clinical application,” said Steve MacDonald MD, Professor at the University of Western Ontario London, Ontario Canada. The clinical trial performed in Canada demonstrated excellent interface stability between the prosthesis and bone as evidenced by RSA. In the FDA IDE Clinical Trial, multiple outcomes are being evaluated.

Total hip replacements can be a very effective way to relieve joint pain and improve function for patients who have advanced hip problems. According to the American Academy of Orthopaedic Surgeons, over 450,000 hip implants are performed in the United States each year.

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