The U.S. Food and Drug Administration gave approval Friday to a new drug-eluting stent for use in treating patients with narrowed coronary arteries.
The Endeavor Zotarolimus-Eluting Coronary Stent, manufactured by Medtronic Inc., of Minneapolis, is the first such stent OK'd since 2004 and the first since an agency panel convened in 2006 to examine the risk of blood clots occurring in patients who receive drug-eluting stents.
Stents are tiny mesh tubes positioned in an artery to act as a scaffold that keeps a clogged artery open. Stents can be bare-metal or drug-eluting -- coated with drugs -- to ensure that the artery doesn't re-close in a process call restenosis.
According to the FDA, Medtronic provided data from seven clinical trials in its application showing that the Endeavor significantly reduced the number of major coronary events such as heart attack or cardiac death. The company said use of its product cut the restenosis rate by about half.
"The Endeavor drug-eluting stent provides cardiologists with another option for treating the one million patients who undergo an angioplasty procedure every year to open their clogged coronary arteries," said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health.
U.S. Women's Heart Disease Deaths Continue to Decline
Heart disease deaths among American women declined again in 2005, marking the sixth consecutive year of decreases, according to a new analysis announced Friday by the U.S. National Heart, Lung, and Blood Institute.
It's the first time there's been a six-year consecutive decline.
The preliminary data analysis for 2005, the most recent year for which statistics are available, shows that women are living longer and healthier lives, and dying at much older ages than in the past.
"Considerable progress continues to be made in the fight against heart disease in women," NHLBI Director Dr. Elizabeth G. Nabel said in a prepared statement.
However, she noted there are still serious challenges. One in four women dies from heart disease and women of color have higher rates of some risk factors for heart disease and are more likely to die of the disease.
"Unfortunately, many women still do not take heart disease seriously and personally," Nabel said. "Millions of women still have one or more risk factors for heart disease, dramatically increasing their risk of developing heart disease. In fact, having just one risk factor increases a woman's chance of developing heart disease two-fold."
An NHLBI-sponsored campaign called "The Heart Truth" is striving to educate people that heart disease is largely preventable. As part of that campaign, Friday is National Wear Red Day, when thousands of people across the country wear red to give women a personal and urgent reminder about their risk for heart disease.