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 CLOSURE I, a randomized trial comparing PFO closure using the...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?