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PFO Closure: Challenges and Opportunities

Executive Summary

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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SeptRx Inc.

Patent foramen ovale can be a contributing factor for stroke, chronic migraine, decompression sickness and obstructive sleep apnea. SeptRx Inc.'s percutaneous device for treating PFO is unique in that it mirrors the anatomy of the flat tunnel of tissue that characterizes PFO. Not only is the device itself flat, but its frame laterally stretches the tunnel to keep it flat and bring the tissue surfaces in contact.

PFO Closure: Where Do We Stand?

The PFO (patent foramen ovale) closure market has certainly traveled a long and twisted road over the years. And the journey isn't over yet. Although some large companies have pulled back on their US commercialization efforts or decided to exit the field entirely, othrs continue to stick it out, hoping the eventual opportunity will far outweigh the risks and costs involved. In Europe, where percutaneous PFO closure following stroke/TIA is more widely accepted and performed, there are nine CE marked PFO closure devices available from eight different manufacturers, with two more devices expected to be added to the mix in the near future. But despite widespread European acceptance, manufacturers have so far failed to achieve the ultimate goal: US regulatory approval.

PFO Closure: Where Do We Stand?

The PFO (patent foramen ovale) closure market has certainly traveled a long and twisted road over the years. And the journey isn't over yet. Although some large companies have pulled back on their US commercialization efforts or decided to exit the field entirely, othrs continue to stick it out, hoping the eventual opportunity will far outweigh the risks and costs involved. In Europe, where percutaneous PFO closure following stroke/TIA is more widely accepted and performed, there are nine CE marked PFO closure devices available from eight different manufacturers, with two more devices expected to be added to the mix in the near future. But despite widespread European acceptance, manufacturers have so far failed to achieve the ultimate goal: US regulatory approval.

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