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Print Edition StoriesFriday, March 19, 2010
FDA gives nod to Boston Scientific defibrillator
By Mass High Tech staff
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Boston Scientific Corp. reports that the U.S. Food and Drug Administration has approved a new use for one of its defibrillator products.
The FDA’s Circulatory Systems Devices Panel has approved the use of Boston Scientific’s (NYSE: BSX) cardiac resynchronization therapy defibrillators (CRT-D) to treat heart failure in patients with asymptomatic or mild heart failure. That would include patients with Left Bundle Branch Block (LBBB) morphology, a condition that delays the activation of the parts of the left ventricle, causing it to contract out of synch with other parts of the left ventricle and the right ventricle, reducing the heart’s pumping ability.
The company said it is the only defibrillator approved for the condition.
Earlier this month, Natick-based Boston Scientific’s stock dropped more than 11 percent afer it announced it would temporarily halt shipments and recall inventory of several brands of implantable heart defibrillators because parts of the manufacturing process have not been approved by the FDA.
Also this month, the FDA approved a Boston Scientific heart stent system intended to improve bloodflow to the legs, using a balloon-expandable stent approved for use in treating iliac artery disease.
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