Hip surgeons in Japan who are looking for a novel tool for primary and revision total hip arthroplasty now have a new option. Intellijoint Surgical Inc., based in Kitchener, Ontario, has just announced that it has gained market authorization from the Japanese Pharmaceutical and Medical Device Agency (PMDA) for Intellijoint HIP and will begin distribution through an existing partner in Japan.
According to the company, Intellijoint HIP is an “easy-to-use, surgeon-controlled navigation system that provides real-time measurements to optimize implant alignment and positioning during hip replacement surgery.” With a learning curve of five cases or less, says the company, Intellijoint HIP is accurate to within half a millmeter when it comes to offset, to within less than half a millimeter on leg length, and to within less than three degrees.
“Gaining entry into the largest computer-assisted surgical navigation market is a major milestone for our team” says Armen Bakirtzian, co-founder and CEO at Intellijoint. ”We are marching forward on our mission to improve patients’ lives by providing every surgeon with effective, easy-to-use technology.”
Intellijoint HIP, already available in the U.S., Canada and Australia, has been used in 20,000 cases since being launched in 2016.
When OTW asked for background on the process of getting market authorization in Japan, Armen Bakirtzian commented, “The approval process by the PMDA was unlike any other market authorization Intellijoint has received in the past. We are proud to be successful in the process in a way that enables market access with direct control.”
Homing in on the value of this market entry, Bakirtzian added, “The Japanese market is the largest computer-assisted surgical navigation market. In addition, it has established reimbursement for surgical navigation and a high yearly growth rate of arthroplasty procedures.”
