STJ’s Amplatzer cardiac implant device hit with FDA safety alert

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St. Jude Medical NYSE:STJSt. Jude Medical (STJ) received an FDA safety alert for its Amplatzer ASO, a minimally-invasive implantable cardiac device used to treat atrial septal defect. The problem? In one to three of every 1,000 patients, ”¬†tissue surrounding the Amplatzer ASO can break down (erode) and result in life-threatening emergencies that require immediate surgery.”

More on the potential device malfunction:

The device rubbing against the wall of the heart can erode the tissue and create a hole. It can also lead to further scraping or erosion through tissue in the upper chambers (atria) of the heart, primarily in the top of the atria near the aorta. This scraping may also cause separate or simultaneous holes in the aortic root, potentially leading to blood building up in the sac surrounding the heart (cardiac tamponade). If too much blood builds up in this sac, the heart will not be able to work properly.

More than 200,000 have been sold since March 31. The FDA doesn’t recommend removing the device from patients who have already had it implanted. Instead, the agency advises physicians to consider potential for erosion and talk about it with patients, as well as educating patients to “seek immediate medical attention if they develop symptoms such as chest pain, numbness, sudden weakness, dizziness, fainting, shortness of breath, or rapid heartbeat.”

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Lindsey Alexander

By Lindsey Alexander

Lindsey Alexander is an Indiana-based freelance writer and editor covering the medical device industry. She earned a degree in journalism from Indiana University and a master's from Purdue.
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