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PFO Closure: Where Do We Stand?

Executive Summary

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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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.

Recent Developments in PFO Closure

The patent foramen ovale closure market has continued to mature in 2009, with the latest round of developments reported at the 2009 Transcatheter Cardiovascular Therapeutics meeting, recently held in San Francisco. Over 60 presentations related to PFO closure or atrial septal defect closure were presented at TCT this year, more than double the amount of PFO-related talks presented in 2008.

Recent Developments in PFO Closure

The patent foramen ovale closure market has continued to mature in 2009, with the latest round of developments reported at the 2009 Transcatheter Cardiovascular Therapeutics meeting, recently held in San Francisco. Over 60 presentations related to PFO closure or atrial septal defect closure were presented at TCT this year, more than double the amount of PFO-related talks presented in 2008.

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