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And elucidating

For "on-label" applications, the FDA "believes that coronary drug-eluting stents remain safe and effective when used for the FDA-approved indications.

These devices have significantly reduced the need for a second surgery to treat restenosis for thousands of patients each year." with worse outcomes for the patients in both studies.

And elucidating

The stent is usually placed within the peripheral or coronary artery by an interventional cardiologist or interventional radiologist during an angioplasty procedure.

Macrophages accumulate around the stent, and nearby smooth muscle cells proliferate.

These physiological changes, which can cause restenosis, are limited by the drugs released by the stent, but these drugs also limit formation of a new endothelial layer over the new stent to inhibit clot formation.

Drug-eluting stents in current clinical use were approved by the FDA after clinical trials showed they were statistically superior to bare-metal stents for the treatment of native coronary artery narrowings, having lower rates of major adverse cardiac events (usually defined as a composite clinical endpoint of death myocardial infarction repeat intervention because of restenosis).

Clinical trials have shown the benefits of coronary stenting with bare-metal stents over other methods of angioplasty, including balloon angioplasty and atherectomy.

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