A hand-held robotic “smart drill” for use in partial-knee replacements is making its debut at the British Orthopaedic Association in September. Already approved for use in Europe, the Navio PFS system is aiming, next year, at the American market. Blue Belt Technologies, Inc. President and CEO Eric Timko, says the company has already applied for approval from the U.S. Food and Drug Administration and hopes to have approval by year’s end “with full commercialization in the U.S. in 2013, ” according to Steve Twedt of the Pittsburgh Post-Gazette in the August 10 press release.
In the Navio system, the surgeon’s orthopedic drill is placed inside a holder equipped with robotic and navigation software. This gives the surgeon detailed information about the positioning and anatomy of the patient’s knee joint, as well as three-dimensional visualization on a computer screen. Company officials say that this prevents surgeons from cutting excess bone or damaging surrounding tissue as they shape the bone to fit the implant.
Twedt quotes Costa Nikou, Blue Belt’s director of software development, saying,
The system allows you to get it right the first time.” Timko added, “This is a tool for the mid-sized hospital, the community hospital. The goal with us is that the surgeon who does 10 [partial-knee replacement surgeries] a year will have the same outcomes as the guy who does 100 a year.
According to Timko, fewer than 500, 000 partial-knee replacements are done worldwide each year, compared with 1.4 million full-knee procedures. But with the precision of the Navio system guiding the surgeon, he believes 20% to 30% of those full-knee operations could be done as partial procedures. “Then you’re looking at a market that is almost $900 million.” Currently, anywhere from 2% to 5% of partial-knee replacements have to be redone within a year.
HealthpointCapital, a New York-based private equity firm, purchased Blue Belt last year. Timko says the company plans to move production to Minneapolis later this year, but the research and development team will remain in Pittsburgh.
