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St. Jude Medical Announces First Implant in Its Migraine Headache Study

Posted on: Tuesday, 18 April 2006, 09:00 CDT

St. Jude Medical, Inc. (NYSE:STJ) today announced the implant 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 implanted patient, a 53-year-old woman from Va., is one of approximately 500 patients who are expected to participate in the study. The 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. The ESCAPE Migraine trial received approval from the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) in December 2005.

Migraine is a neurological disorder characterized by chronic and disabling headaches. Approximately 12 percent of the population suffers from the disorder, and it has a prevalence rate estimated as high as 20 percent in young women. Many patients do not use existing migraine therapies because they are ineffective or because they result in unwanted side effects.

"The goal of this trial is to determine if closing a PFO will significantly reduce migraine attacks, which routinely debilitate people and prevent them from working, socializing and enjoying a reasonable quality of life," said David W. Dodick, M.D., Mayo Clinic College of Medicine, Scottsdale, Ariz., 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 migraine are more likely to have a PFO, and if it is repaired, migraine attacks may be reduced," said John Porter, M.D., the enrolling physician of the first implanted patient, a neurologist with Salem Neurological Center and Clinical Research of Winston-Salem, N.C. "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."

The first patient was implanted with St. Jude Medical's Premere PFO Closure System, which is specifically designed for PFO closures and was part of the product portfolio acquired by the Company through the 2005 acquisition of Velocimed, LLC. 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 close the PFO. Implanted through a transcatheter approach, this procedure is less invasive than open-heart surgeries to close PFOs.

"Although some people with a PFO experience no symptoms, others may suffer a stroke or decompression illness (which may accompany activities like scuba diving), and there may even be a mechanism where a PFO is associated with migraine headaches," said John Rhodes, M.D., the first implanting physician and an interventional cardiologist with the Duke University Heart Center in Durham, N.C. "Now that catheter closure of a PFO has become a common procedure for recurrent stroke patients, PFO closure for migraine headaches is an intriguing application of this technology. We are very excited at Duke to be involved in this important research and are hopeful it will improve the quality of life for many people with migraine headaches. "

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 suggest reduced migraine attacks after PFO closure. It is not clear why patients with migraine would be more likely to have a PFO, or why closing the PFO might decrease migraine attacks. Some physicians speculate that blood that crosses the PFO, without being filtered by the lungs, contains substances that trigger migraines.

The ESCAPE Migraine trial is a controlled, randomized, blinded study to determine if PFO closures 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.

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

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

About St. Jude Medical

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, Minn., the Company employs approximately 10,000 people worldwide. For more information, please visit www.sjm.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, regulatory approvals, anticipated future product launches, revenues, earnings, and market shares. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company's control and the risk factors and other cautionary statements described in the Company's filings with the SEC, including the risk factors described in the Company's Annual Report on Form 10-K filed on March 16, 2006 (see Item 1A on pages 15-21). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

Source: Business Wire

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