Tags: Heart Disease | FDA | review | dissolving | heart | stent

FDA to Review Dissolving Heart Stent

FDA to Review Dissolving Heart Stent
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Tuesday, 15 March 2016 08:48 AM

Possible approval of a heart stent that dissolves into the body after helping open clogged arteries will be discussed by a U.S. Food and Drug Administration advisory panel.

Stent maker Abbott Laboratories is seeking FDA approval for the first-of-kind Absorb device, but the agency has questions about its safety and effectiveness, the Associated Press reported.

An FDA review posted last week said a company study showed that rates of cardiovascular complications were slightly higher with Absorb than with a conventional metal stent, and that the risk of complications was higher when Absorb was used in smaller arteries.

The panel of outside experts will discuss available data about Absorb and advise the FDA on whether the device should be approved. The agency typically follows the recommendations of its advisory panels, the AP reported.

The Absorb stent is already sold in Europe.

© HealthDay


   
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Possible approval of a heart stent that dissolves into the body after helping open clogged arteries will be discussed by a U.S. Food and Drug Administration advisory panel. Stent maker Abbott Laboratories is seeking FDA approval for the first-of-kind Absorb device, but the...
FDA, review, dissolving, heart, stent
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2016-48-15
Tuesday, 15 March 2016 08:48 AM
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