A Medical Device Daily

NMT Medical (Boston) said that the first patients have been randomized in its pivotal patent foramen ovale (PFO)/migraine trial in the U.S. — MIST II, designed to evaluate the safety/efficacy of its BioSTAR implant for the treatment and prevention of migraine headaches in patients with a patent foramen ovale (PFO) hole in the heart.

The randomization took place at the Swedish Medical Center (Seattle, Washington). The trial currently is being conducted at more than 25 sites across the country. Stewart Tepper, MD, and Mark Reisman, MD, are co-principal investigators of MIST II.

“MIST II is a landmark trial that will advance the collective understanding within the medical community of the potential link between PFO and migraine headaches,” said Reisman. “The patients enrolled in MIST II will benefit from the only clinical trial which utilizes a device made of bioabsorbable collagen matrix material designed to promote closure of structural heart defects, such as PFO. In addition, MIST II is supported by evidence from a predicate PFO/migraine study, MIST, and several retrospective studies at various medical centers throughout the world.”

A double-blinded trial, MIST II is designed to randomize about 600 migraine patients with PFO to either PFO closure with Biostar or a control arm. More than 50 migraine headache specialists and interventional cardiologists are participating.

NMT makes implant technologies for treatment of structural heart disease via catheter-based procedures.