FDA Approves New Medical Device to Treat Those Facing Coronary Artery Disease

Coronary artery disease is a condition which occurs when arties become narrowed or blocked by a buildup of plaque. Plaque deposits which cause the blockage or narrowing of the arteries consist of cholesterol, white blood cells, calcium, and scar tissue which have accumulated on the artery wall. Blood is oxygen rich and also carries vital nutrients, so blockage of a coronary artery can lead to shortness of breath, chest pain, heart attacks, and possibly death. On November 1, 2011, the Food and Drug Administration approved two versions of a medical device known as an Everolimus, Eluting Coronary Stent System. These devices are inserted into a blood vessel and advanced into the compromised coronary artery. Using a balloon, which inflates to expand the clogged blood vessel, a stint is inserted to achieve the desired expansion and help keep the artery open. A drug contained within the stint, designed to maintain the open flow of blood, is then released over time to help ensure continued effectiveness. The FDA has determined that those who cannot receive anti-platelet and/or anticoagulant therapy, those who have lesions which would prevent the inflation of the angioplasty balloon, and those who are hypersensitive to everolimus should not use this device. For more information on this device, check out the approval announcement issued by the FDA on their website. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm278523.htm

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