On June 22, 2017, Exactech, Inc. announced that it had won Japanese approval for its shoulder, knee and hip replacement systems and that the devices had been recently used in their first procedures in the region.
Exactech Wins Japanese Approval for Joint Replacement Devices
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Officials of the Gainesville, Florida-based company said they won regulatory approval to introduce additional products from its three segments to the Japanese market, including its Optetrak Logic CR knee system, Novation crown cup acetabular component, Alteon tapered wedge stem and Equinoxe reverse shoulder systems.
The first procedures with all of the devices were performed between April 6 and June 5, the company said.
“Exactech has maintained direct distribution in Japan since 2008 with consistent growth. These new product introductions are important milestones for Exactech in one of our key global markets. We are pleased to expand our offerings with these important innovations to better serve surgeons and patients,” said Sales & Marketing Development Vice-President Daniel Berdat in a press release.
In February, Exactech announced that it had sold its spine business to ChoiceSpine for an undisclosed amount and plans to restructure its biologics business.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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