STJ ST. Jude Medical, Inc.

Data from a clinical trial show that a new device from St. Jude Medical, Inc., (NYSE:STJ) is effective in treating a common condition associated with more than 200,000 strokes worldwide each year. The PFO (patent foramen ovale) CLOSE UP (Closure Using Premere(TM)) Trial results were presented this week at the Cardiovascular Research Foundation's Seventeenth Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium by Principal Investigator Horst Sievert, M.D., Professor of Internal Medicine, Cardiology and Vascular Medicine at the CardioVascular Center Frankfurt, Sankt Katharinen, Frankfurt, Germany. PFOs, or patent foramen ovale, are common defects where a small hole between the upper chambers of the heart can allow unfiltered venous blood to enter the arterial circulation. If the unfiltered blood contains a clot or other debris, it can trigger a stroke or transient ischemic attack (TIA, or "mini-stroke"). While everyone is born with a PFO and most close naturally during infancy, approximately 25 percent of the adult population has a PFO, which is usually considered benign in most people. The Premere(TM) PFO Closure System (20mm) device safely and effectively closed PFOs in 87 percent of cases after six months with no adverse events. The trial included 67 patients at five research sites in Europe. Premere was specifically designed for PFO closures. During the procedure, physicians deliver the device through the PFO and then open its two sides independently, allowing physicians to precisely place the device and close the PFO. The Premere(TM) device is implanted through a transcatheter approach, which is far less invasive than open heart surgery. "The Premere(TM) design conforms well to PFO anatomy, using materials that minimize complications, limit the body's exposure to foreign material and enable physicians to precisely place the device," said Paul R. Buckman, president of St. Jude Medical's Cardiology Division. "The absence of complications during the trial confirms the device was successful in meeting these important clinical objectives." Strokes occur when an artery bursts or is blocked, which denies oxygen to the brain and leads to loss of function. It is estimated that more than 2 million patients worldwide suffer strokes each year, 10 percent of which are associated with PFOs. TIAs temporarily interrupt the brain's blood supply. While they do not have lasting effects, they are warning signs of a stroke, and one-third of people with TIAs eventually experience a stroke, too. Medical researchers have observed that patients whose PFOs have been closed appear to have less recurrence of strokes. In December 2004, Premere(TM) received European CE Mark approval for sale in Europe and select international markets. Premere(TM) is only available for investigational use in the United States. There is evidence that PFOs also are associated with migraine headaches; in the U.S., the device will be used in the ESCAPE clinical trial (Effect of Septal Closure of Atrial PFO on Events of Migraine with Premere) under an approved Investigational Device Exemption to study the effect of PFO closure on migraine attacks. The ESCAPE trial (www.ESCAPEmigraines.com) is expected to begin in late 2005. 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 St. Jude Medical'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 Company's 8-K filed October 17, 2005. Actual results may differ materially from anticipated results.