St. Jude Medical® Trifecta™ Valve – P100029
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: St. Jude Medical® Trifecta™ Valve
PMA Applicant: St. Jude Medical
Address: 177 East County Road B, St. Paul, MN 55117 USA
Approval Date: April 20, 2011
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf10/p100029a.pdf
What is it? The Trifecta valve is a three-leaflet stented pericardial valve designed for supra-annular placement in the aortic position. The Trifecta valve is intended as a replacement for a diseased, damaged or malfunctioning aortic heart valve. The valve leaflets are manufactured using bovine (cow) pericardial tissue. A polyester-covered titanium stent supports the bovine pericardial tissue. The stent, excluding the sewing cuff, is covered with porcine (pig) pericardial tissue. This covering provides protection from mechanical wear by allowing only tissue-to-tissue contact during valve function.
How does it work? At certain times, the cusps (flaps) of the valve open and let blood through, and at other times, the cusps close to hold back the blood.
When is it used? When the valves in your heart do not open and close properly, you begin to become short of breath, dizzy, have chest pains, fatigue, or retain fluids. The doctor can listen to your heart with a stethoscope, or do an ultrasound (a type of moving picture of the valves that is taken using sound waves) to see if it is functioning properly. Valves can be malformed at birth, or become damaged or diseased, or a previous artificial heart valve may begin to malfunction, and these need to be replaced.
What will it accomplish? Once replaced, the clinical symptoms should lessen or go away, and the doctor will hear that the valve is working better, or see that it is working better with an echocardiogram (picture of the heart).
When should it not be used? There are no known contraindications.
Additional information: Summary of Safety and Effectiveness and labeling are available online.