STJ ST. Jude Medical, Inc.

St. Jude Medical, Inc. (NYSE:STJ) announced today that it has received conditional approval from the U.S. Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) to begin enrollment in the ESCAPE (Effect of Septal Closure of Atrial PFO on Events of Migraine with Premere(TM)) migraine trial. St. Jude Medical believes it is the first company to receive FDA conditional approval to study the potential connection between Patent Foramen Ovale (PFO) closure and migraine headaches. A PFO is a structural defect of the heart where a small hole between the right and left atria (upper chambers of the heart) fails to close in infancy. An estimated 25% of the adult population has a PFO but in most people it is usually considered benign. The ESCAPE clinical trial is a prospective, randomized, two-arm, double-blind multi-center trial. The objective is to determine if patients who undergo a PFO closure procedure have a decreased number of migraines over a one year follow-up period as compared to those who are maintained only on drug therapy. Enrollment in the study is expected to begin by the end of 2005. "We are very pleased to receive conditional approval to begin this important effort to study the effects of PFO closure on migraine sufferers," said Paul Buckman, President of St. Jude Medical's Cardiology Division. "Recurrent migraines are very difficult for physicians to manage and are debilitating for many patients. We believe that this study could provide important clinical insights into their future treatment." Migraines are a neurological disorder characterized by chronic and disabling headaches. Approximately 10-12% of the population is estimated to suffer from this disorder. It is the most common type of headache in young adults and has a prevalence rate estimated as high as 25% in young women. While there is currently only anecdotal proof of a cause-effect relationship between migraine and PFO, several clinical experiences have confirmed a strong association between the presence of PFO and migraines. Analysis by several physicians have shown that closure of PFO in patients with migraine and a previous stroke has been associated with a reduction in both intensity and frequency of migraine attacks. The ESCAPE trial will be conducted using the Premere PFO closure system, which is a percutaneous transcatheter device that closes the PFO. This device incorporates unique features for PFO closure including: -- Flexible, low profile anchors that conform to the septal wall; -- Independent anchors to position for precise placement; -- Limited surface area and prosthetic material designed to encourage rapid endothelialization and minimize the incidence of thromboembolic complications; and -- Adjustable tether to adapt to the varying patient anatomies. St. Jude Medical added the Premere PFO closure system to its portfolio through the acquisition of Velocimed, LLC in April 2005. The Premere PFO closure system already has CE Mark approval in Europe but is not labeled for the treatment of migraines. St. Jude Medical, Inc. (www.sjm.com) is dedicated to the design, manufacture and distribution of innovative medical devices of the highest quality, offering physicians, patients and payers outstanding clinical performance and demonstrated economic value. Any statements made regarding the Company's anticipated future product launches, regulatory approvals, revenues, earnings, market shares, and potential clinical success are forward-looking statements which are subject to risks and uncertainties, such as those described in the Financial Section of the Company's Annual Report to Shareholders for the fiscal year ended December 31, 2004 (see page 16). Actual results may differ materially from anticipated results.