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Occlutech: Fighting IP Wars in PFOs

Executive Summary

For most small device companies, the threat of IP litigation sends chills through senior management. But for PFO start-up, its current battle with AGA Medical can only help, say company officials, by establishing the bona fides of its technology in a crowded space.

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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: 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.

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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