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.

A roundup of recent medtech strategic alliances, mergers & acquisitions and financings.

Sometimes an unconventional device company needs an unconventional investor. That's true of mNemoscience, which was launched from the MIT lab of Robert Langer to develop materials technology that combines the shape memory properties commonly associated with nitinol and biodegradability. The combined properties could represent important advances in a number of device areas, and the company is starting in coronary stents and sutures. But, not surprisingly, mNemoscience has taken a long time in its technology development efforts and has had to find just the right financing model. What mNemoscience had to offer its unconventional investor provides an instructive tale to medtech executives and scientists everywhere.