Stents - small tubes used to hold heart vessels open after angioplasty - are an important part of modern, minimally invasive treatment for heart disease. An important potential complication of stent use is the development of blood clots that can lead to heart attack or stroke. To combat this risk, modern stents are manufactured with anti-clotting drugs built in to the stent itself. After implantation, the stents "elute" the drug in the area around the implant site, theoretically lowering the risk of clot related complications.
Because of ongoing data reports showing some confusion about the use and benefits of drug-eluting stents the US Food and Drug Administration (FDA) has proposed a new set of guidelines that makers must follow when seeking FDA approval for new stents. These new guidelines take aim specifically at patient centered issues and at helping doctors better understand which stent to choose to improve patient care. Specifically, the guidelines say that makers must provide data on how effective the stents are at reducing patient deaths, how often patients develop blood clots, and how easy (or hard) it is to complete follow up treatment and care on patients who have the stents implanted.
The FDA has stated that new guidelines represent the agency's ongoing efforts to make data clear and appropriate for health care professionals who need to formulate effective treatment plans.
