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: Resolute Integrity Zotarolimus-Eluting Coronary Stent System (Resolute Integrity)
PMA Applicant: Medtronic Vascular, Inc
Address: 3576 Unocal Place,
Santa Rosa, CA 95403
Approval Date: February 22, 2013
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf11/p110013S005a.pdf
What is it? The Resolute Integrity stent is a metal stent with the drug zotarolimus contained in a thin coating on the stent’s surface. It uses the same stent design, base material, and manufacturing process as the approved uncoated Integrity Coronary Stent. The Resolute Integrity stent uses the same drug as the approved Endeavor Zotarolimus-Eluting Coronary Stent. However, the Resolute Integrity stent uses a different polymer in the drug-polymer stent coating and a different delivery system than the Endeavor system.
The Resolute Integrity 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).
How does it work?
- A catheter with a small balloon mounted on the end is inserted into a blood vessel in the groin or arm and advanced into a coronary artery.
- The catheter is then positioned at the narrowed portion of the artery and the balloon is inflated. As the balloon inflates, it stretches the coronary artery wall (a procedure known as balloon angioplasty).
- The balloon is then deflated, and the catheter is removed from the artery.
- The Resolute Integrity stent delivery catheter is then positioned at the narrowing of the coronary artery. The balloon on the stent delivery catheter is inflated, which expands the stent and presses it against the coronary artery wall. This may be followed by repeated 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 drug (zotarolimus) is released over time into the artery wall around the stent to help prevent the vessel from re-narrowing.
When is it used? The Resolute Integrity stent is used in patients who have a 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 scar tissue that collect over time in the coronary artery wall. If these arteries become blocked or narrowed, treatment may be required to improve blood flow and increase the supply of oxygen to the heart.
The Resolute Integrity stent is used in patients, including those with diabetes, who have narrowing in coronary arteries with a length less than or equal to 35 mm with reference vessel diameters of greater than or equal to 2.25 mm to less than or equal to 4.2 mm.
What will it accomplish? A significantly narrowed coronary artery limits blood flow to the heart muscle and can cause chest pain (angina). Placement of the Resolute Integrity stent within the narrowed coronary artery improves blood flow. After a coronary artery stent is implanted, re-narrowing of the artery may occur. The drug (zotarolimus) is released over time from the Resolute Integrity stent surface into the nearby artery wall to help prevent re-narrowing of the vessel.
When should it not be used? The Resolute Integrity Zotarolimus-Eluting Coronary Stent System should not be used in patients who:
- cannot receive antiplatelet and/or blood-thinning (anticoagulation) therapy.
- have a lesion that prevents complete angioplasty balloon inflation or proper placement of the stent or stent delivery system.
- have known hypersensitivity or allergy to aspirin, heparin, bivalirudin, clopidogrel, prasugrel, ticlopidine, zotarolimus, tacrolimus, sirolimus, everolimus, or similar drugs or any other analogue or derivative.
- have a known hypersensitivity or contraindication to structurally-related compounds cobalt, nickel, chromium, molybdenum, acrylic, and fluoropolymers.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.