NMT Medical trial will evaluate migraine, heart defect connection

By Lisa Kerner

Erie, Pa., Jan. 11 - NMT Medical, Inc. has begun enrollment in its PFO/migraine clinical study known as MIST II (Migraine Intervention with STARFlex Technology). The U.S. study will evaluate the safety and effectiveness of NMT's proprietary STARFlex implant technology for the treatment and prevention of migraine headaches.

The study targets patients with a common heart defect, known as patent foramen ovale (PFO), thought to be a potential risk factor for migraine headaches. The PFO allows unfiltered venous blood that may contain migraine-triggering elements to enter the arterial blood circulation.

The PFO defect has been linked to increased risk of migraine headaches, recurrent stroke and transient ischemic attacks.

Of the 28 million migraine sufferers in America, approximately 3 million experience aura and have a PFO, according to a company news release. Stroke is the third leading cause of death in the United States. Annually, 750,000 Americans suffer a new or recurrent stroke and 500,000 Americans experience a TIA.

The double-blinded multi-center prospective trial is designed to randomize approximately 600 migraine patients with a PFO to either PFO closure with STARFlex technology or a control arm. More than 40 migraine headache specialists and interventional cardiologists are committed to participate in MIST II.

Enrollment is currently expected to be complete by the end of 2006. Patient follow-up will continue over a one-year period. MIST results are expected by April.

"Progress in this trial is an important step forward in defining the company's technological and clinical research leadership in this emerging field. We believe we are the first company to enroll patients in a PFO/migraine IDE study approved by the U.S. Food and Drug Administration," said John E. Ahern, NMT president and chief executive officer, said in the release.

Stewart Tepper and Mark Reisman are the co-principal investigators of the MIST II clinical trial. Tepper is director of The New England Center for Headache in Stamford, Connecticut. Reisman is director of cardiovascular research at Swedish Medical Center, Seattle, Washington.

NMT has five separate PFO-related trials currently underway. MIST II is the second PFO/migraine trial initiated by NMT, said the company. NMT was the first to receive approval for and to complete enrollment in a PFO/migraine study in the United Kingdom.

NMT Medical designs, develops and markets proprietary implant technologies for the treatment of cardiac sources of migraine headaches, stroke and other potential brain attacks through minimally invasive, catheter-based procedures. The company is based in Boston.

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