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News From the Food and Drug Administration
April 3, 2018

New Stent for Small Vessels

JAMA. 2018;319(13):1314. doi:10.1001/jama.2018.2942

The smallest drug-eluting stent (DES) available in the United States has received FDA approval. At 2.0 mm, the new stent is intended to help interventional cardiologists treat patients with coronary artery disease whose small vessels often can’t be treated with larger stents during percutaneous coronary intervention.

Approval of the Resolute Onyx 2.0 mm DES was supported by data presented at the 2017 EuroPCR annual meeting for interventional cardiologists. The clinical study involved 101 patients with coronary lesions between 2.0 and 2.25 mm in diameter. Patients were enrolled at 20 sites in the United States and Japan.

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