Consumer Information on: ION? Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire Delivery Systems) - P100023/S015
This is a brief overview of information related to FDA’s approval to market this product for an expanded indication. 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: ION™ Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire Delivery Systems)
PMA Applicant: Boston Scientific Corporation
Address: One Boston Scientific Place, Natick, MA 01760-1537
Approval Date: February 22, 2012
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf10/p100023s015a.pdf
What is it? The ION™ Paclitaxel-Eluting Coronary Stent is a metal stent with a drug (paclitaxel) contained in a thin coating on the stent’s surface. The stent is mounted on a folded balloon attached to a catheter delivery system for placement into a coronary artery (blood vessel supplying blood to the heart). The ION™ stent is already FDA-approved for certain uses, and uses the same drug-coating formulation as the TAXUS® Express2® and TAXUS® Liberté® stents.
How does it work?
- A catheter with a deflated balloon at its tip is inserted into a blood vessel in the arm or groin, and advanced within the vessel to the narrowed or blocked section of the coronary artery.
- The balloon is inflated to open the artery by pushing the plaque against the artery wall (a procedure known as balloon angioplasty. The balloon is then deflated and removed from the artery.
- Then the stent, mounted on another deflated balloon catheter (the stent delivery catheter), is advanced through the same vessel and positioned within the expanded coronary artery. The balloon is inflated, which expands the stent and presses it against the coronary artery wall. This may be followed by repeat balloon inflations within the stent to achieve the desired stent expansion.
- The stent remains permanently implanted within the coronary artery to help keep the artery open. The balloon is deflated and removed from the patient. The drug (paclitaxel) is released over time into the artery wall around the stent to help prevent the vessel from narrowing again.
When is it used? The stent is used in patients who have a narrowing or blockage in their coronary arteries (blood vessels supplying blood to the heart) caused by atherosclerosis -- the collection of fatty substances such as cholesterol that forms “plaque” along the lining of the arteries. 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 improve blood flow and increase the supply of oxygen to the heart. This approval expands the list of FDA-approved uses of the ION™ stent to include treatment of patients after a heart attack (ST-elevation myocardial infarction, or STEMI).
What will it accomplish? Placement of a stent within a narrowed or blocked coronary artery opens the artery allowing more blood flow to the heart. If the narrowing is not treated, it can cause chest pain (angina) or can lead to a heart attack or even death. Sometimes, after a coronary artery stent procedure, the artery can narrow again. The drug (paclitaxel) is released over time from the stent surface into the nearby artery wall to help prevent re-narrowing of the vessel.
When should it not be used? The ION™ Paclitaxel-Eluting Coronary Stent System should not be used in patients:
- who cannot take aspirin or blood-thinning medicine.
- who have an allergy to the metal in the stent, the drug paclitaxel (or related drugs), or the polymers used to coat the stent.
- who have a blockage in the coronary artery that will not allow complete inflation of the balloon or proper placement of the stent.
Additional Information: The Summary of Safety and Effectiveness Data and labeling are available online.