One month ago today, an orthopedic surgeon in Belgium performed the first partial-knee replacement on a patient using a hand-held "smart drill" developed by a team of robotics, mechanical engineering and software development specialists at Blue Belt Technologies Inc. in the Strip District.
If the success of that operation is any indication, the Navio PFS system could soon be introduced to the U.S.
Already approved for use in Europe, the Navio PFS system will be formally introduced to the entire European orthopedic community next month at the British Orthopaedic Association meeting in Manchester, England.
Then it's on to the U.S.
Blue Belt 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 that by year's end "with full commercialization in the U.S. in 2013."
With the Navio system, the standard surgeon's orthopedic drill is placed inside a holder equipped with robotic and navigation software.
The combination gives the surgeon real-time information about the positioning and anatomy of the patient's knee joint, as well as three-dimensional visualization on a computer screen. That, in turn, helps surgeons avoid cutting excess bone or damaging surrounding tissue as they shape the bone so the implant will fit well.
"The system allows you to get it right the first time," said Costa Nikou, Blue Belt's director of software development.
Orthopedic surgeon Brian Hamlin, who practices at the bone and joint center at Magee-Womens Hospital of UPMC and is on Blue Belt's scientific advisory board, said the ability to correctly place the implant "will allow for durability and long-term success for your patients."
Currently, anywhere from 2 to 5 percent of partial-knee replacements have to be redone within a year, possibly because the alignment is wrong, or the implant has shifted, or simply because the patient is still in pain.
"Although we try to do it with precision and accuracy -- and I think we get reasonably good results -- with more precise and more accurate information, our outcomes will improve and more patients will have better long-term results," said Dr. Hamlin.
"Having that information from the software is quite valuable."
Mr. Timko said 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, he believes 20 to 30 percent of those full-knee operations could be done as a partial procedure. "Then you're looking at a market that is almost $900 million."
More important, he said, this is a platform technology that can be adapted and used for other orthopedic procedures -- "anywhere there's bone that needs to be shaped precisely," said Mr. Timko.
In the past year, Blue Belt was bought by the New York private equity firm HealthpointCapital and has grown from nine to 22 employees locally. Mr. Timko said the company plans to move production to Minneapolis later this year because of the wealth of vendors and suppliers there, but the research and development team, comprised largely of graduates from Carnegie Mellon University and the University of Pittsburgh, will stay here.
While another company already has an interactive robotic arm on the market that can do knee replacements, Mr. Timko believes "our technology will jump leaps and bounds ahead of them" at what he says will be about one-third the cost for the equipment.
"This is a tool for the mid-sized hospital, the community hospital," Mr. Timko said. "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."
Steve Twedt: firstname.lastname@example.org or 412-263-1963. First Published August 10, 2012 4:00 AM