Randomized clinical trials investigating percutaneous patent foramen ovale (PFO) closure in the US have continued to progress in 2010. These trials are striving to gather data that would support Premarket Application approval by the US Food & Drug Administration (FDA), which would allow for the first FDA-approved indication specifically for the closure of PFO. ( See Exhibit 1.)
In April, NMT Medical Inc. achieved an important milestone with the lock down and initiation of data analysis for...