Trifecta Valve Overview:
The Trifecta Valve is a tri-leaflet pericardial valve designed for supra-annular placement in the aortic position.
Important Information:
The valve is intended as a replacement for a diseased, damaged, or malfunctioning native aortic heart valve.
Do not resterilize the valve by any method. Use only the Model TF-1000 or TF2OOO Trifecta Valve Sizer Set for sizing a Trifecta Valve.
Passage of a catheter or transvenous pacing lead through any bioprosthesis may damage the valve and is therefore not recommended.
Use caution when tying knots to avoid bending the stent posts. Never handle the leaflet tissue.
Precautions:
The valve is not designed for use in the following specific populations: patients who are pregnant, nursing mothers, patients with chronic renal failure, patients with aneurysmal aortic degenerative conditions, patients with active endocarditis, patients requiring pulmonic or tricuspid valve replacement, children, adolescents, or young adults.
Do not use the valve if the shipping temperature indicators on the product carton have turned red, or if the valve has been improperly stored in temperature conditions outside of the 5’C to 25°C (39°F to 77°F) range.
Do not attempt to repair a valve. Damaged valves must not be used.
Avoid prolonged contact with the formaldehyde storage solution. Immediately after contact, thoroughly flush any skin exposed to the solution with water.
Manual:
Download: DRAFT TRIFECTA INSTRUCTIONS FOR USE (WORD FORMAT) Trifecta Valve
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