This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: XIENCE™ V Everolimus Eluting Coronary Stent on the Over-the-Wire (OTW) or Rapid Exchange (RX) Stent Delivery Systems
PMA Applicant: Abbott Vascular (A subsidiary of Abbott Laboratories, Inc.)
Address: 3200 Lakeside Drive, Santa Clara, CA 95054 USA
Approval Date: July 2, 2008
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf7/p070015a.pdf
What is it? The XIENCE V Stent is a metal scaffold with the drug everolimus contained in a thin coating. The XIENCE V Stent is mounted on a folded balloon attached to a catheter delivery system, for placement into the coronary artery (blood vessel supplying blood to the heart). The stent is made of a cobalt-chromium metal alloy and comes in multiple sizes, in order to treat coronary arteries of different sizes.
How does it work? Initially, a catheter with a small balloon mounted on the end is inserted into a blood vessel in the arm or groin, and advanced within the vessel to the narrowed section of the coronary artery. The catheter is then positioned at the narrowed portion of the artery and the balloon is inflated. As the balloon inflates, it pushes out against the wall of the coronary artery and compresses the plaque (balloon angioplasty). The balloon is then deflated and the catheter is removed from the artery.
The XIENCE V delivery system with a pre-mounted stent is then advanced through the same vessel (arm or groin) and positioned within the newly expanded coronary artery. The balloon is then inflated, which opens the stent and presses it against the coronary artery wall. This may be followed by repeat balloon inflations within the stent to expand it further. The stent remains permanently within the coronary artery to help keep the artery open. The drug (everolimus) is released over time from the stent into the artery wall to help prevent the vessel from re-narrowing.
When is it used? The XIENCE V stent is used in patients who have a significant narrowing in their coronary arteries caused by coronary artery disease – a condition that occurs when the arteries that supply oxygen-rich blood and nutrients to the heart muscle become narrowed or blocked by a gradual build-up of “plaque.” Plaque is made up of fatty deposits (cholesterol), white blood cells, calcium, and other substances that collect over time in the wall of a coronary artery. If these arteries become blocked or narrowed, treatment may be required to increase blood flow and the vital supply of oxygen to the heart.
What will it accomplish? Placement of the XIENCE V stent within the narrowed coronary artery improves blood flow. If the narrowed coronary artery is not treated, there could be a gradual reduction of blood flow to the heart muscle that can cause chest pain (angina). A heart attack (myocardial infarction) can occur if the artery suddenly becomes blocked, usually by a blood clot that forms over ruptured (broken) plaque. Heart attacks can cause irreversible damage to the heart muscle or even death. After a coronary artery stent procedure, re-narrowing of the artery may occur. The drug (everolimus) is released over time into the artery wall around the stent to help prevent the vessel from re-narrowing.
When should it not be used? The XIENCE V Everolimus Eluting Coronary Stent System should not be used in patients:
- who cannot receive antiplatelet and/or anti-coagulant therapy,
- who have lesions that prevent complete angioplasty balloon inflation, or
- who have known hypersensitivity or contraindication to everolimus or structurally-related compounds, cobalt, chromium, nickel, tungsten, acrylic, and fluoropolymers.
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p070015