Newswise — A more flexible drug-eluting stent studied in clinical trials at the Methodist DeBakey Heart & Vascular Center has been approved by the FDA, and Methodist physicians were the first in Houston to implant the new device.
The design of the new stent, the first approved by the FDA in four years, allows it to be placed in hard to reach blockages .Research conducted at Methodist was pivotal in the Phase 3 trial that led to FDA approval of the stent.
"This stent is unique because it is designed in a way that it can go where other stents can't, such as in twisting, tortuous arteries that are difficult to access. If cardiologists can reach the diseased artery with this stent, we don't have to send the patient to surgery," said Dr. Stuart Solomon, interventional cardiologist at the Methodist DeBakey Heart & Vascular Center and principal investigator on the trial. "Our research has also shown strong results in terms of safety and effectiveness."
In February Medtronic's Endeavor stent received FDA approval for treatment of coronary artery disease, which affects 13 million Americans and is the country's leading cause of death.
Stents are tiny wire mesh tubes used to prop open coronary arteries to restore blood flow to the heart. Drug-eluting stents deliver medication to the artery wall to reduce the chance that the artery will narrow again and require a repeat procedure.
Methodist cardiologists have been pioneers in the research and development of coronary stents, and some of these first stents were implanted at Methodist 20 years ago. Since then, more than 100,000 stents have been used to open arteries in patients at Methodist. More recent research conducted at Methodist over the past five to 10 years has also helped fine-tune treatment for patients who have drug-eluting stents, making post treatment safer and more effective with the use of anti-platelet therapy.
About the Endeavor studyThe Endeavor study submitted the largest, most wide-ranging patient population submitted to the FDA in support of a drug-eluting stent, including more than 4,100 patients, followed up for as long as four years. This clinical research has shown that Endeavor provides a consistent and sustained reduction in the need for repeat procedures compared to a bare-metal stent, while also maintaining an excellent safety profile.
For more information on the Methodist DeBakey Heart & Vascular Center, see http://www.debakeyheartcenter.com.
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