On-X LTI products are manufactured and sold under one or more of the following U.S. Patents:
- U.S. Patent No.5,137,532
- U.S. Patent No.5,308,361
- U.S. Patent No.5,545,216
- U.S. Patent No.5,262,104
- U.S. Patent No.5,284,676
- U.S. Patent No.5,305,554
- U.S. Patent No.5,328,713
- U.S. Patent No.5,332,337
- U.S. Patent No.5,336,259
- U.S. Patent No.5,514,410
- U.S. Patent No.5,677,061
- U.S. Patent No.6,274,191
- U.S. Patent No.6,096,075
- U.S. Patent No.5,772,694
- U.S. Patent No.5,641,324
- U.S. Patent No.5,976,183
- U.S. Patent No.5,843,183
- U.S. Patent No.5,908,452
- U.S. Patent No.6,059,826
- U.S. Patent No.6,062,075
- U.S. Patent No.6,315,793
- and corresponding foreign patents.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
INDICATIONS FOR USE: The On-X® Prosthetic Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position.
CONTRAINDICATIONS: The On-X® Prosthetic Heart Valve is contraindicated for patients unable to tolerate anticoagulation therapy.
WARNINGS AND PRECAUTIONS:
- FOR SINGLE USE ONLY.
- DO NOT use the On-X® Prosthetic Heart Valve if:
- the prosthesis has been dropped, damaged, or mishandled in any way.
- the tamper evident seal is broken.
- the serial number tag does not match the container label.
- the expiration date has elapsed.
- DO NOT resterilize any On-X® Prosthetic Heart Valve once it is removed from its plastic container.
- DO NOT resterilize more than 3 times.
- DO NOT resterilize with any method other than steam sterilization, with the identified resterilization parameters.
Note: Gamma radiation is known to damage the sewing ring.
- DO NOT pass a catheter, surgical instrument, or transvenous pacing lead through the prosthesis as this may cause valvular insufficiency, leaflet damage, leaflet dislodgment, and/or catheter/instrument/lead entrapment.
- Handle the prosthesis with only On-X LTI On-X® Prosthetic Heart Valve Instruments. Only On-X LTI On-X® Prosthetic Heart Valve sizers should be used during the selection of the valve size; other sizers may result in improper valve selection.
- Avoid damaging the prosthesis through the application of excessive force to the valve orifice or leaflets.
- Avoid contacting the carbon surfaces of the valve with gloved fingers or any metallic or abrasive instruments as they may cause damage to the valve surface not seen with the unaided eye that may lead to accelerated valve structural dysfunction, leaflet escape, or serve as a nidus for thrombus formation.
POTENTIAL ADVERSE EVENTS:
Adverse events potentially associated with the use of prosthetic heart valves (in alphabetical order) include, but are not not limited to: angina, cardiac arrhythmia, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, myocardial infarction, prosthesis leaflet entrapment (impingement), prosthesis non-structural dysfunction, prosthesis pannus, prosthesis perivalvular leak, prosthesis regurgitation, prosthesis structural dysfunction, prosthesis thrombosis, thromboembolism and stroke. It is possible that these complications could lead to: reoperation, explantation, permanent disability and death.