Boston Scientific lands FDA clearance for new CRT lead delivery system

May 13, 2010 by MassDevice staff

Boston Scientific Corp. wins 510(k) clearance from the Food & Drug Administration for its new Acuity Break-Away lead delivery system for cardiac resynchronization therapy devices.

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Boston Scientific Corp. (NYSE:BSX) won 510(k) clearance from the Food & Drug Administration for a new lead delivery system for its cardiac resynchronization therapy devices.

The device is designed to reduce the risks associated with implanting CRT device leads, the wires that conduct electrical signals via blood vessels from a pacemaker or defibrillator into the heart.

The Natick, Mass.-based company said the new, smaller-diameter leads can access veins of various sizes and feature a break-away hemostasis valve designed to minimize blood loss and shorten implant time.

Boston Scientific recently hit a few snags with its own CRT devices. The company held shipment of the devices for one month after missing a pair of FDA filings, costing it an estimated $5 million a day.

Yesterday, San Clemente Calif.-based Cameron Health Inc. released clinical trial results from a study of its new subcutaneous defibrillator at the Heart Rhythm Society's 31st Annual Scientific Session that has the ability to stimulate the heart without leads.