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Published on 4/18/2006 in the Prospect News Biotech Daily.

FDA approves St. Jude Medical's heart failure lead delivery system

By Lisa Kerner

Erie, Pa., April 18 - St. Jude Medical, Inc. said the Food and Drug Administration approved its Cardiac Positioning System family of lead delivery tools designed to give physicians greater control and precision when implanting cardiac resynchronization therapy devices, such as defibrillators or pacemakers, in heart failure patients.

"The Cardiac Positioning System enables faster, easier procedures with clearly visible three-dimensional markers to guide implantation," Thomas A. Mattioni of the (Phoenix) Arizona Arrhythmia Consultants said in a company news release.

Features of the new Cardiac Positioning System include an inner guide catheter designed to form a telescope, enabling other medical instruments to reach the desired location and a bideflectable catheter with one-hand steering.

St. Jude Medical said studies show that cardiac resynchronization therapy can improve quality of life for heart failure patients by reducing symptoms like fatigue and shortness of breath.

Heart failure, affecting about 5 million Americans, is a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood to the body, the release stated.

St. Jude is a medical device technology and services company located in St. Paul, Minn.


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