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: ION™ Paclitaxel-Eluting Coronary Stent System (Monorail and Over-The-Wire Systems)
PMA Applicant: Boston Scientific Corporation
Address: One Scimed Place Maple Grove, MN 55311
Approval Date: April 22, 2011
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf10/p100023a.pdf
What is it? The ION Paclitaxel-Eluting Coronary Stent is an expandable, mesh-like stainless steel tube with a drug (paclitaxel) contained within a thin polymer coating on its surface. The stent is mounted over a deflated balloon attached to the end of a long, thin, flexible tube-like device called a stent delivery catheter.
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 section of the coronary artery.
- The balloon is inflated within the narrowed artery to open the artery by pushing the plaque against the artery wall (balloon angioplasty).
- The angioplasty balloon and its catheter are withdrawn from the patient; then the stent, mounted on another deflated balloon catheter (the stent delivery catheter), is advanced through the same vessel and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 on the stent delivery catheter is inflated, causing the stent to expand to the size and contours of the vessel. This restores the opening in the artery, allowing normal blood flow to the heart.
- The balloon on the stent delivery catheter is then deflated and the delivery catheter without the stent is removed from the patient.
- The stent remains permanently implanted within the coronary artery, acting as a support (scaffold) for the newly opened section of the vessel.
- The drug (paclitaxel) is released into the artery wall around the stent to help prevent the vessel from re-narrowing.
When is it used? The ION stent is used in patients who have a significant narrowing in their coronary arteries (blood vessels supplying blood to the heart) 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.
The ION stent is to be used in patients who have narrowing in arteries that are greater than or equal to 2.25 mm to less than or equal to 4.0 mm in diameter and where the narrowed part of the artery is less than or equal to 34 mm long.
What will it accomplish? Expansion of the stent within the narrowed section of a coronary artery opens the narrowing, allowing more blood flow to the heart. If the narrowing is not treated, it can lead to a heart attack (myocardial infarction) or even death. Sometimes, after a coronary artery stent procedure, re-narrowing of the artery occurs. This is due to overgrowth of normal tissue that occurs during the healing process. The drug (paclitaxel) is intended to limit this overgrowth of normal tissue.
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 (antiplatelet and/or anti-coagulant therapy),
- who have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device, or
- who have known hypersensitivity or contraindication to paclitaxel or structurally related compounds, 316 L stainless steel or platinum, and the polymers used to coat the stent.
Additional information : Summary of Safety and Effectiveness and labeling are available online.