REBEL Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) - P130030

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: REBEL Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) (REBEL Stent System)
PMA Applicant: Boston Scientific Corporation
Address: One Scimed Place, Maple Grove, MN 55311

Approval Date: June 27, 2014

Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130030a.pdf

What is it? The REBEL Stent System consists of a bare metal stent and a delivery catheter. The stent is made from a platinum chromium alloy and is used to treat coronary artery disease. The stent is the same design as the Promus Premier Stent, but without the drug component. The delivery catheter is used to place the REBEL Stent into a diseased/narrowed blood vessel (coronary artery) supplying oxygen-rich blood to the heart muscle. The REBEL Stent System is only for single-use.

How does it work? A REBEL stent is placed on the end of a delivery catheter with a small balloon mounted on the end. This System is inserted into a blood vessel in the groin or arm and advanced, under fluoroscopy, into the coronary artery. With the help of a guidewire, the catheter is positioned across the diseased/narrowed portion of the coronary artery that needs to be widened. The balloon is then inflated, expanding the stent and the coronary artery. The stent is pressed against the coronary wall where it will remain permanently implanted to help keep the coronary artery open. The delivery of the stent may be followed by repeated balloon inflations within the stent to achieve the desired result. Over time, the coronary artery wall will heal around the stent as it continues to support the coronary artery.

When is it used? The REBEL Stent System 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 become narrowed or blocked by a gradual build-up of “plaque.” Plaque is made of fatty deposits (cholesterol), white blood cells, calcium, and scar tissue that collect over time in the coronary artery. If these arteries become blocked or narrowed, treatment may be required to improve blood flow.

What will it accomplish? A significantly narrowed coronary artery limits blood and oxygen flow to the heart and can cause chest pain as well as damage the heart muscle. Placement of the REBEL Stent within the narrowed coronary artery improves blood flow. The stent remains in the artery to help maintain the improved blood flow.

When should it not be used?
The REBEL Stent System should not be used in patients with the following:

  • Known hypersensitivity to platinum, platinum chromium alloy, or similar alloy types such as stainless steel.
  • Known severe reaction to iodinated fluid (contrast media) used during the procedure to see internal structures and who cannot be adequately pre-medicated prior to the REBEL Stent placement procedure.
  • Patients who cannot receive recommended medications that thin the blood and prevent blood clots.
  • Patients judged to have a coronary lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device.

Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.