St. Jude Medical Applauds the Centers for Medicare & Medicaid Services Announcement of...

Business Editors & Health/Medical Writers

ST. PAUL, Minn.--(BUSINESS WIRE)--Sept. 26, 2001

St. Jude Medical, Inc. (NYSE:STJ) today announced its support of the Centers for Medicare & Medicaid Services (CMS) intent to cover anticoagulation home monitoring for Medicare

St. Jude Medical is the world's leading mechanical heart valve company. Mechanical valves are the most durable and long-lasting heart valve prostheses available. Many St. Jude Medical(R) valves have been implanted for more than twenty years.

All patients who receive mechanical heart valves, however, require lifelong anticoagulation medication ("blood thinner") to reduce the risk of blood clots. This medication must be monitored and adjusted for each individual. Regular blood tests are performed at a doctor's office or lab to ensure the proper level of medication.

Studies have shown that St. Jude Medical(R) mechanical heart valve patients who use self-testing devices are more often in their targeted therapeutic range for anticoagulation medication and, as a result, have a lower rate of complications. By allowing patients to test more frequently using self-testing devices, doctors can adjust medication dosages and improve the effectiveness of anticoagulation therapy.

"We strongly support the CMS announcement of its intent to provide coverage for this important tool in the management of anticoagulation therapy for mechanical heart valve patients who are eligible for Medicare," said Steven J. Healy, President of St. Jude Medical's Cardiac Surgery Division. "The data shows that patient self-monitoring contributes to improved patient outcomes and can potentially reduce costs in the treatment of heart valve patients. At St. Jude Medical, we share the surgeons' and patients' goal of having only One Valve for Life(SM). The CMS announcement is an important component of our program."

St. Jude Medical estimates there are currently 500,000 mechanical heart valve patients in the United States, with 42 percent over the age of 65 and thus eligible for Medicare.

On Sept. 5, 2001, St. Jude Medical and LifeScan, Inc., a Johnson & Johnson company, announced an exclusive U.S. marketing alliance to promote a new anticoagulation blood monitoring system, the Harmony(TM) INR Monitoring System, which is developed by LifeScan and recently received U.S. Food and Drug Administration (FDA) clearance. The new system, which consists of a handheld electronic monitor and disposable, single-use test strips, is similar in concept and testing technique to the blood glucose meters used to self-test blood glucose levels by millions of people with diabetes.

More than 1.15 million patients worldwide have received St. Jude Medical(R) mechanical heart valves, an achievement far surpassing any other heart valve supplier. The St. Jude Medical(R) mechanical heart valve is known for its innovative bileaflet design, superior hemodynamics, ease of implantability and outstanding durability.

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 unmatched clinical performance and demonstrated economic value.