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Ground-breaking Stent Approved for Clogged Heart Arteries

By ALM Staff | Law Journal Newsletters |
April 01, 2003

The FDA has just approved (April 24) the first drug eluting stent for angioplasty procedures to open clogged coronary arteries. In most cases, a stent is left permanently in the artery to keep the vessel open after angioplasty. The new stent slowly releases a drug, and has been shown in clinical studies to significantly reduce the rate of re-blockage that occurs with existing stents.

Drug-eluting stents may have a substantial impact on the occurrence of re-blockages for patients with heart disease. Each year 800,000 angioplasty procedures are performed in the United States to open clogged coronary arteries. In approximately 15% to 30% of patients, the artery becomes clogged again (a condition called restenosis) within a year, and it must be treated again with a procedure such as angioplasty or bypass surgery. Health and Human Services' Secretary Tommy Thompson noted that patients who receive this device will need fewer repeat operations to unclog arteries, which can make a real difference in the quality of their lives.

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