St. Jude Medical to test if treatment of common heart defect alleviates migraines

By Lisa Kerner

Erie, Pa., March 2 - St. Jude Medical, Inc. said it has the enrolled the first of 500 patients in its ESCAPE (Effect of Septal Closure of Atrial PFO on Events of Migraine with Premere) migraine trial.

Patent foramen ovale (PFO) is a common heart defect, often without symptoms, that has been linked to stroke, decompression illness and migraine headaches, according to a company news release.

The controlled, randomized, blinded study will evaluate the benefit of treating this defect with St. Jude Medical's Premere PFO Closure System in patients with migraine headaches.

The catheter closure of a PFO is a simple 30-minute procedure that has been shown to eliminate migraine headaches in many stroke sufferers, the company said.

"While the connection between a heart defect and head pain may seem counterintuitive, there is growing evidence that patients with migraines are more likely to have a PFO, and if repaired, it may lead to a reduction in migraine attacks," principal neurology trial investigator David W. Dodick said in the release.

The study received approval from the Food and Drug Administration for an Investigational Device Exemption in December.

"Migraine is one of the 20 most disabling conditions that exists, according to the World Health Organization, and despite many good medications that help control the disease, millions of patients continue to suffer," Neil Pugach, the first enrolling physician and a neurologist with the Brighton Research Group in Virginia Beach, Va., said in the release.

"Some patients struggle with the idea of having to take daily medications to treat their migraines, so it is exciting to think that an alternative treatment might prove successful."

St. Jude Medical is based in St. Paul, Minn. and develops medical device technology and services for the treatment of chronic pain and cardiac and neurological diseases.

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