Symmetry Medical Inc. has announced that it received FDA 510(k) clearance for its FLASH PAK Evolution valve. The Evolution valve is the next generation valve for Symmetry’s market leading, immediate use (flash) sterilization product, FLASH PAK, and is distributed exclusively through Symmetry Surgical. The patent pending stainless steel construction of the new valve is designed for ease of use and simplicity of care.
Symmetry: 510(k) Clearance for Evolution Valve
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Chris Huntington, chief operating officer of Symmetry Surgical, said in the August 28, 2012 news release, “Making care and maintenance of our products easy is a key mission of Symmetry Surgical. The Evolution valve brings a new level of innovation to our market leading FLASH PAK; a product that clinicians have grown to depend on for over 20 years.”
Huntington told OTW,
Evolution is the next generation valve for our FLASH PAK sterilization product, controlling airflow into and out of the system. Once the valve is closed, it does not allow ambient air in, nor does it allow air out, thus keeping the sterility of the items in the container intact. In designing and developing the Evolution valve, we focused on enhancing both ease of use and simplicity of maintenance, which were top voice of the customer requirements. We also wanted to ensure that our new valve was backwards compatible with our existing FLASH PAK product.
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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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