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news.NMT Medical has announced that the first patients have been randomized in its pivotal patent foramen ovale/migraine MIST II trial in the US, which is designed to evaluate the safety and effectiveness of its BioSTAR implant technology for the treatment and prevention of migraine headaches in patients with patent foramen ovale.
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A patent foramen ovale (PFO) is a common heart defect that may be a potential risk factor for migraine headaches in some patients. The PFO allows venous blood, unfiltered and unmanaged by the lungs, to enter the arterial blood circulation. The unfiltered venous blood may contain elements that can trigger migraines in some patients.
MIST II is a prospective, randomized, multi-center, controlled study. The double-blinded trial is designed to randomize approximately 600 migraine patients with a PFO to either PFO closure with NMT’s implant technology or a control arm. More than 50 leading migraine headache specialists and interventional cardiologists are participating in MIST II.
Patients enrolled in MIST II will receive the world’s first bio-absorbable implant, BioSTAR, which achieved a post-implant complete closure rate of 92% at 30 days and 96% at six months. Over time, 90% to 95% of the BioSTAR implant is absorbed and replaced with the patient’s native tissue, providing a more natural, biological closure of their PFO. BioSTAR is currently available for commercial use in Europe and Canada.