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Coherex Medical Inc.

This article was originally published in Start Up

Executive Summary

These are tough times for companies developing PFO closure devices. Various energy-based approaches have hit the rocks, and clinical trial enrollment difficulties have derailed others. Coherex Medical hopes for better results with technology that it describes as safe, user-friendly, and more effective than competing technologies. The company's FlatStent PFO closure system combines a self-expanding stent with tissue growth materials, and a design that provides multiple means to close the PFO and thus boost the chances for long-term success.

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Over the past several years, device manufacturers have introduced a number of PFO closure devices in Europe, but conducting randomized trials to gain US market approval has proven to be a much more difficult endeavor. Companies have experienced numerous delays and setbacks in both their stroke and migraine programs. The good news: setbacks for some could also boost randomized migraine studies still ongoing by other competitors in this field.

PFO Closure: Challenges and Opportunities

Over the past several years, device manufacturers have introduced a number of PFO closure devices in Europe, but conducting randomized trials to gain US market approval has proven to be a much more difficult endeavor. Companies have experienced numerous delays and setbacks in both their stroke and migraine programs. The good news: setbacks for some could also boost randomized migraine studies still ongoing by other competitors in this field.

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