NMT Medical Commences Patient Randomization In MIST II PFO/Migraine Trial
Boston, MA - NMT Medical, Inc. recently announced that the first patients have been randomized in its pivotal patent foramen ovale (PFO)/migraine trial in the United States, MIST II. The MIST II trial is designed to evaluate the safety and effectiveness of NMT's BioSTAR implant technology for the treatment and prevention of migraine headaches in patients with PFO. The randomization took place at the Swedish Medical Center in Seattle, Washington. The trial currently is being conducted at more than 25 sites across the country.
Stewart Tepper, MD and Mark Reisman, MD are the co-principal investigators of the MIST II clinical trial. Dr. Tepper is Director of The New England Center for Headache in Stamford, Connecticut. Dr. Reisman is Director of Cardiovascular Research at Swedish Medical Center, Seattle, Washington. Doctors Reisman and Amish Desai of the Swedish Medical Center were involved in the randomization.
"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 Dr. 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."
"Randomizing the first patients in the MIST II trial is an important clinical milestone for us," said President and Chief Executive Officer John E. Ahern. "While it has taken longer to reach this point than we had anticipated, it was time well-spent and we are enthusiastic about the prospects for this comprehensive trial. In order to ensure statistically relevant results, we developed a thorough screening process to include only patients that would benefit most from PFO treatment."
A 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.
As mentioned, patients enrolled in MIST II will receive the world's first bioabsorbable implant, BioSTAR. As reported in NMT's BEST (BioSTAR Evaluation STudy) trial, BioSTAR 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.
For more information about NMT Medical, please visit www.nmtmedical.com.
SOURCE: NMT Medical, Inc.