PipelineReview.com - Biotech News & Online Store - First Patient Enrolled in St. Jude Medical's Migraine Headache Study; Clinical Trial to Explore Link between Common Heart Defect and Migraine Headaches

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

03 Mar 2006

ST. PAUL, MN, USA | Mar 02, 2006 | 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.

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 anticipated future product launches, regulatory approvals, revenues, earnings, market shares, and potential clinical success. 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 Cautionary Statements section in Item 2 of the Company's Quarterly Report on Form 10-Q filed on November 8, 2005 (see page 35). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

CONTACT: St. Jude Medical, Inc., St. Paul
Investor Relations:
Laura Merriam, 651-766-3029
or
Media Relations:
Charlotte Fransen, 651-490-4393

SOURCE: St. Jude Medical, Inc

Search in our News Channels

Search in our Online Store