First Patient Enrolled in St. Jude Medical's Migraine Headache Study; Clinical Trial to Explore Link between Common Heart Defect and Migraine Headaches

Business Wire, March 2, 2006

ST. PAUL, Minn. -- St. Jude Medical, Inc. (NYSE:STJ) today announced the enrollment of the first patient in its ESCAPE (Effect of Septal Closure of Atrial PFO on Events of Migraine with Premere(TM)) migraine trial.

The first patient, a Virginia woman, will be one of over 500 patients to participate in the study, which received approval from the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) in December 2005.

"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," said Dr. Neil Pugach, the first enrolling physician, a neurologist with the Brighton Research Group in Virginia Beach, Virginia. "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."

"Patent foramen ovale (PFO) is a common heart defect without symptoms in most people," said Robert Sommer, M.D., Columbia Presbyterian Hospital, principal cardiology investigator for the trial. "However, PFOs have been linked to stroke and decompression illness (which may accompany activities like scuba diving), and it appears that PFOs may also play a prominent role in migraine headaches. The goal of this landmark trial is to determine if closing a PFO will help in reducing migraine attacks."

Migraine headaches are a neurological disorder characterized by chronic and disabling headaches. Approximately 10 percent of the population suffers from the disorder, and it has a prevalence rate estimated as high as 25 percent in young women.

"This trial will examine the benefit of treating a common heart defect - patent foramen ovale - in patients with migraine headaches," said David W. Dodick, M.D., Mayo Clinic College of Medicine, principal neurology investigator of the trial. "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. This is an exciting area of research into a chronic and disabling disease that affects millions of Americans, and I am enthusiastic about playing a role in this carefully controlled landmark U.S. study, which could answer these very important questions."

"Stroke prevention is an important aspect of PFO repair," said Dr. Sommer. "But migraine headaches are a part of daily life for nearly 30 million Americans. Current migraine therapies are difficult to take because of side effects, and the treatments are often ineffective. The catheter closure of a PFO is a simple 30-minute procedure that has been shown to eliminate migraine headaches in many stroke sufferers. If successful, this trial will have a major impact on the quality of life of millions of people."

The association between PFOs and migraine headaches was first observed by physicians who treated PFOs to remedy other medical conditions such as stroke; these physicians later noticed a reduced frequency in patients' migraine headaches. Additional informal studies have shown reduced pain - after PFO closure - for migraine patients. It is not clear why patients with a PFO would be more likely to have migraines, or why closing the PFO might decrease migraine attacks. Some physicians speculate that blood that crosses the PFO, without being filtered by the lungs, has substances that trigger migraines.

The ESCAPE trial is a controlled, randomized, blinded study to determine if PFO closures will actually reduce the frequency of migraine headaches enough to be a therapy option for patients with migraines. The study will be conducted at 45 leading headache clinics and 15 leading interventional cardiology clinics throughout the United States.

St. Jude Medical's Premere(TM) PFO Closure System, which will be used in the ESCAPE study, was specifically designed for PFO closures and was part of the product portfolio acquired by the Company through the 2005 acquisition of Velocimed. During the implant procedure, physicians deliver the device through the PFO and then open the device's two sides independently, allowing physicians precise placement to effectively close the PFO. Implanted through a transcatheter approach, this procedure is far less invasive than open-heart surgeries previously used to close PFOs.

In December 2004, Premere(TM) received CE Mark approval for sale in Europe and select international markets indicated for the closure of a patent foramen ovale. Premere(TM) is only available for investigational use in the United States.

For more information about the ESCAPE trial, go to www.ESCAPEmigraines.com.

St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology, and neuromodulation. Headquartered in St. Paul, Minnesota, the company employs approximately 10,000 people worldwide. For more information, please visit www.sjm.com.