Hip Replacement Guiding Tool Cleared by FDA
Canadian start-up Intellijoint Surgical said Tuesday it received FDA clearance to market the Intellijoint HIP, the company’s sole product. The miniature smart tool guides surgeons during hip replacement surgery.
In particular, the Intellijoint HIP helps to ensure correct leg length and hip offset — the main sources of patient displeasure with hip replacement, the Waterloo, Ontario, company said. The device should reduce liabilities and costs associated with hip implant failure and repeat surgeries, which exceed $1 billion in annual costs to the U.S. healthcare system, the devicemaker added.
The tool — two miniature sensors that are placed in the sterile field and communicate with a portable display — quantifies the measurements, normally left to the surgeon’s personal judgment, that are needed to position the implant. The process adds only a few minutes to a surgery, according to the company.
Intellijoint CEO Armen Bakirtzian told Device Daily Bulletin the Intellijoint HIP will be released immediately in the Eastern U.S. The tool is already approved in Canada, and the company plans to pursue a CE mark as well. — Kellen Owings
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