Boston Scientific gets FDA Acuity OK |
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Published
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Tue, 17 Apr 2007 16:15
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NATICK, Mass. (AP) - Medical device maker Boston Scientific Corp. said Tuesday that the Food and Drug Administration approved one of its heart device leads, its first new product since the agency lifted a hold on company approvals.The FDA approved the Acuity steerable left ventricular lead, an electrode system that can be placed within the heart by snaking it through blood vessels. The lead is to be used with the company's implantable defibrillators and pacemakers that provide cardiac resynchronization therapy.The Acuity lead also allows doctors to change the site of stimulation by reprogramming the device instead of having to perform another surgery, the company said. Boston Scientific plans to launch the Acuity in July.The device is the first new Boston Scientific product approved since the Food and Drug Administration lifted restrictions from a warning letter on Monday concerning the company's St. Paul, Minn. cardiac rhythm management device plant. The lifting of restrictions also allowed the approval of five software upgrades for heart devices.Boston Scientific shares added 2 cents to $16.02 in morning trading on the New York Stock Exchange.Copyright 2007 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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