The folks at Integra LifeSciences Holding Corporation are celebrating. The FDA has granted a 510(k) clearance for its Titan Reverse Shoulder System. The company plans to begin a limited market release of the system in the U.S. in the third quarter of 2013 and, upon CE Mark clearance in Europe, initiate a full global commercial launch.
Integra’s Titan (Reverse Shoulder) Lifts Off
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Secondary
Integra officials explain that the Reverse Shoulder System is built on a platform stem, which simplifies the conversion of a primary total shoulder, or hemi for fracture, to a reverse shoulder, without the need to remove a stem that is well-fixed in the patient’s bone. The system offers fully interchangeable components, allowing all primary, reverse, and fracture humeral bodies to be used with either the press-fit or cemented platform stems.
Analysts anticipate that the global shoulder replacement market will reach nearly $865 million in 2014 and $1.3 billion by 2017. With the addition of the Titan Reverse Shoulder System that addresses both the press-fit and cemented reverse shoulder market, Integra believes that it is well positioned to gain a key foothold in this rapidly growing market.
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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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