St. Jude Medical announces exclusive European co-promotion alliance with HemoSense Inc.

St. Paul 28 July 2005St. Jude Medical Inc. has signed an exclusive agreement in most European countries with HemoSense Inc. to increase awareness and access to self-testing and monitoring the effectiveness of anticoagulation medication or Coumadin or warfarin for mechanical heart valve patients. Mechanical heart valve patients take blood-thinning medication to minimize the risk of thrombolic events and, as a result, regularly monitor their anticoagulation levels, a measurement expressed in International Normalized Ratio (INR).

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INR self-testing may provide major cost savings to insurers, since anticoagulation therapy-related complications, that could potentially be prevented by more frequent and convenient screening at home, can exceed U.S. $10.000 or 8286 euro per episode if the patient needs to be hospitalized. Studies using other devices have demonstrated that patient INR self-testing is effective in managing Coumadin levels; however, physician and patient awareness of self-testing is still low.

HemoSense's portable INRatio Prothrombin Time (PT) Monitoring System tests PT/INR levels in patients who are taking warfarin, a blood-thinning drug. The St. Jude Medical - HemoSense co-promotion alliance offers a self-testing solution for heart valve patients on anticoagulation therapy.

Under the agreement, St. Jude Medical and HemoSense will develop joint promotional materials, including physician/nurse educational information and patient education programmes for physician-directed patient self-testing of anticoagulation therapy. The companies will also sponsor medical symposia and meetings.

HemoSense's portable system allows patients to self-test their anticoagulation levels at home rather than visiting a clinic or a laboratory. Studies have demonstrated that patients who self-test on a regular schedule have fewer anticoagulation-related complications and stay within their therapeutic range more frequently than patients who do not self-test. Increased time in therapeutic range may lead to improved clinical outcomes.

"We are pleased to enter a co-promotion alliance with HemoSense", stated Denis M. Gestin, President of St. Jude Medical Europe, Middle East, Africa and Canada. "INRatio offers our heart valve patients a convenient PT/INR testing solution, whether they are testing at home or at their health care provider facility."

"Our INRatio monitoring system is a natural fit for St. Jude Medical's mechanical heart valves", stated Jim Merselis, President and CEO of HemoSense. "St. Jude Medical's efforts to offer physicians a mechanical heart valve implementation and INR management programme reflect their commitment to the highest level of patient care and health care cost containment."

St. Jude Medical is a global expert in mechanical heart valve technology and recently implanted its 1,5 millionth mechanical heart valve. Over the past several years, the company's portfolio has expanded to include a line of tissue valves and repair products, making it one of the most diverse cardiac surgery technology platforms in the market.

In the United States, St. Jude Medical has formed an alliance with Raytel Cardiac Services, a wholly owned subsidiary of SHL-Telemedicine Ltd., to promote the benefits of anticoagulation patient self-testing for mechanical heart valve recipients. Raytel's system for remote INR self-testing is called INR@Home.

HemoSense develops, manufactures and sells the INRatio System, an easy-to-use, handheld blood coagulation monitoring system for use by patients and professionals in the management of warfarin medication. INRatio measures the patient's blood clotting time to ensure that patients with a propensity to form clots are maintained within the therapeutic range with the proper dosage of oral anticoagulant therapy. HemoSense Inc. is headquartered in San Jose, California.

St. Jude Medical Inc. is a $2,3 billion global cardiovascular device company headquartered in St. Paul, Minnesota (USA). The company sells products in more than 130 countries and has 20 principal operations and manufacturing facilities worldwide. St. Jude Medical 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.


Leslie Versweyveld

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