A Medical Device Daily

AGA Medical (Minneapolis) said it has enrolled the first patients in its clinical trial, Prospective Randomized investigation to Evaluate the incidence of headache reduction in subjects with Migraine and PFO Using the Amplatzer PFO Occluder compared to Medical Management (PREMIUM), examining connections between certain migraine headaches and a heart defect found in more than 20% of adults. The first patient was enrolled at Abbott Northwestern Hospital (also Minneapolis).

PREMIUM is a randomized, two-arm, double-blind multi-center U.S. trial to determine whether patients who undergo closure of a patent foramen ovale (PFO) with the companyh's Amplatzer device have a reduction in frequency/severity of migraines; it will enroll about 400 patients at up to 35 centers.

AGA said that observational studies have reported a significant number of patients experiencing a reduction in the frequency and severity of migraine headaches following PFO closure.

The Amplatzer PFO Occluder – implanted via a catheter inserted in the patient's groin – is a less-invasive alternative to open heart surgery for PFO closing.

PREMIUM is one of two AGA-sponsored studies exploring the PFO/migraine link. The PRIMA study is under way at sites in Europe and Canada.

“The PRIMA and PREMIUM studies represent significant opportunities to further expand AGA Medical's well established worldwide leadership position in the transcatheter closure of structural heart defects,” said Franck Gougeon, CEO of AGA.