Intellijoint Surgical, Inc. (formerly Avenir Medical) an innovator in smart tools to improve joint replacement surgery, announced today it recently received a Health Canada Medical Device License for its flagship product, Intellijoint HIP™.
The Company also announced early results for its ongoing clinical study with surgeons at Mount Sinai and selected Toronto Area Hospitals showing the Company's smart tool to be significantly more accurate in determining leg length and offset equivalency than traditional measurement methods used in hip replacement.
Intellijoint's proprietary device enables surgeons to quantify the key measurements needed for accurate primary and revision hip replacement. "Receiving Health Canada's license to launch Intellijoint HIP™ in Canada, and our ongoing studies in Toronto Area Hospitals are exciting milestones. " said Armen Bakirtzian, CEO of Intellijoint.
"In addition, we have met the international requirements for our quality management system for the design and manufacture of medical devices; and have submitted our application to the FDA for marketing Intellijoint HIP™ in the United States", said Bakirtzian, speaking about the Company's market opportunity in North America where Intellijoint HIP™, once approved in the US, can potentially be used by surgeons to guide over 500,000 hip replacements a year.
"In hip replacement, many surgeons rely on clinical judgment to position implants and determine leg length and offset," said Dr. Allan Gross, Orthopaedic Surgeon at Mount Sinai Hospital in Toronto, and Chairman of Intellijoint's Scientific Advisory Board. "However, studies in the US and EU show that after hip replacement over 30% of patients have complaints, one third of these have complications due to surgical error, and 7% are readmitted for high cost revision surgery."
"At the same time," noted Dr Gross, "research shows that accurate measurements in hip replacement improve patients' clinical benefits, and lower hospital costs and liabilities. With Intellijoint HIP™, surgeons now have a time and cost saving smart tool for the operating room that enables them to accurately perform hip replacement and enhance patient satisfaction."