MRG report says PFO market ‘hot’

Millennium Research Group (Waltham, Massachusetts) has issued a report on Transcatheter Embolization and Occlusion markets in the U.S, saying that “the hottest market” is the patent foramen ovale (PFO) closure device market, part of the heart defect closure segment of the report. “With a patient population close to 1.8 million, the potential of the PFO market is huge and will likely entice entry by medical device companies looking for future growth,” according to Millennium

Historically, the PFO market has been small because both companies in the market only had Humanitarian Device Exemptions (HDE). In August 2006, however, the FDA asked NMT Medical (Boston) and AGA Medical (Golden Valley, Minnesota) to voluntarily remove their HDEs, an event expected to speed clinical trial enrollment and result in a pre-market approval for PFO closure, thus opening the way to many new patients.

“The heart defect market has great potential," said Tyler Fletcher, an analyst at MRG. "With positive trial results for both the stroke and migraine indications, this could become a multi-billion dollar market by 2011.”