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News From the Food and Drug Administration
October 16, 2018

Device Approved to Seal Coronary Artery Perforations

JAMA. 2018;320(15):1528. doi:10.1001/jama.2018.15037

A stent system designed to treat acute coronary artery perforations has received FDA approval, the first such device the agency has cleared in 17 years. Approval was through the humanitarian device exemption process, which is used for devices that treat or diagnose a condition that affects no more than 8000 people a year in the United States.

Acute coronary perforations are rare but potentially life threatening. They can occur during percutaneous coronary intervention (PCI) procedures performed to insert a stent to increase blood flow in arteries narrowed by plaque. Very rarely, a deep tear occurs in the wall of the artery being treated. In some coronary perforations, blood leaking through the tear can lead to potentially fatal pericardial effusion.