St. Jude Medical announces first implant in migraine headache study

By Lisa Kerner

Erie, Pa., April 18 - St. Jude Medical, Inc. said the first patient of 500 patients has received a Premere PFO Closure System implant as part of the Escape (Effect of Septal Closure of Atrial PFO on Events of Migraine with Premere) migraine trial.

The patient is a 53-year-old woman from Virginia, according to a company news release.

The controlled, randomized, blinded trial will explore the link between a common heart defect, called patent foramen ovale (PFO), and migraine headaches to determine if closing the PFO reduces the frequency of migraine attacks, St. Jude said.

The Escape Migraine trial received approval from the Food and Drug Administration for an Investigational Device Exemption in December and will be conducted at 60 leading headache or interventional cardiology clinics in the United States.

Migraine, a neurological disorder characterized by chronic and disabling headaches, affects about 12% of the population.

"While the connection between a heart defect and head pain may seem counterintuitive, there is growing evidence that patients with migraine are more likely to have a PFO, and if it is repaired, migraine attacks may be reduced," neurologist John Porter, the enrolling physician of the first implanted patient, said in the release.

"If the trial confirms that closure of the PFO reduces migraine headaches, it could lead to treatments that could have a major impact on the quality of life of millions of people."

St. Jude is a medical device technology and services company located in St. Paul, Minn.

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