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: Mitroflow Aortic Pericardial Heart Valve
PMA Applicant: CarboMedics, Inc.
Address: 1300 East Anderson Lane, Austin TX 78752-1752
Approval Date: October 23, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/p060038a.pdf
What is it? The Mitroflow Aortic Pericardial Heart Valve is intended for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. The Mitroflow valve consists of a single piece of bovine pericardium that is preserved with glutaraldehyde and sewn onto a polyester covered polymer stent. A radiopaque, silicone sewing ring is attached to the outer perimeter of the inflow side of the valve. The Mitroflow valve is available in aortic sizes 19, 21, 23, 25, and 27 mm diameters.
How does it work? The Mitroflow Aortic Pericardial Heart Valve is a prosthetic heart valve. A prosthetic heart valve serves to replace the natural function of the native heart valve, which directs the flow of blood between chambers of the heart. The prosthetic valve is a passive device that opens and closes under the forces that arise during the natural beating of the heart.
When is it used? The Mitroflow Aortic Pericardial Valve is intended for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
What will it accomplish? A patient who has a diseased, damaged or malfunctioning aortic heart valve may feel weak, tired, or otherwise handicapped. Surgical replacement of the affected valve may be an effective option to improve the patient’s medical condition and quality of life.
When should it not be used? There are no known contraindications for the use of the Mitroflow valve.
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p060038