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A decade ago, incuabators were seen as the best medicine for what then ailed the medical device industry, most notably a complex regulatory pathway and a difficult venture financing climate. Perhaps not surprisingly, as both the regulatory path and venture financing grew easier in the mid 2000s, incubators began to struggle, victims of their own financing problems. More recently, two huge acquisitions, Abbott's purchase of Evalve and Medtronic's of Ardian, suggest that at least one incubator, The Foundry, is proving that incubation works.
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.
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.
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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