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 and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Rithron-XR Coronary Stent System
Applicant: Biotronik GmbH
Address: Woemannkehre 1, Berlin , Germany
Approval Date: April 29, 2005
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/p030037a.pdf
What is it? The Rithron-XR Coronary Stent System consists of a stent and a stent delivery catheter. The stent, an expandable, slotted, stainless steel tube, is mounted over a deflated balloon attached to the end of a long, thin, flexible tube (stent delivery catheter). The stent has gold markers that help the surgeon place it in an artery. The stent and markers are completely coated with silicon carbide. The stent is permanently implanted within the coronary artery, acting as a support (scaffold) for the newly opened section of vessel.
When is it used?
The Rithron-XR is used in patients who have a narrowing 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.
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- The angioplasty balloon and its catheter are withdrawn from the patient.
- The stent is mounted on another deflated balloon catheter (stent delivery catheter), 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 scaffold for the newly opened section of the vessel.
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.
When should it not be used?
The Rithron-XR stent should not be used in patients:
- in whom antiplatelet and/or anticoagulant therapy is contraindicated
- who are judged to have a lesion that prevents complete inflation of an angioplasty balloon
- with known allergies to stainless steel, gold, or silicon carbide
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p030037