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Food & Drug Law Weekly

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Medtronic, Inc.



FDA approves left-heart lead for cardiac resynchronization therapy systems



September 24th, 2004

Medtronic, Inc., (MDT) announced U.S. Food and Drug Administration approval of the Attain 4194 Bipolar over-the-wire left-heart lead for use with cardiac resynchronization systems.

This new steroid-eluting lead has an angled shape and can be inserted using either a guidewire or a stylet delivery method, giving physicians an extra option to successfully maneuver and position the lead in a variety of difficult venous anatomies.

The Attain 4194 lead is the fourth generation of left-heart leads designed for use with the Medtronic InSync family of cardiac resynchronization therapy (CRT) pacemaker and defibrillator systems. Leads are thin, insulated wires...


Source: Food & Drug Law Weekly (2004-09-24)

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