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UC202408098a EN
Crescent™* jugular dual lumen catheter is manufactured by MC3, Inc. and exclusively distributed by Medtronic.
Penditure™ LAA Exclusion System
Indications:
The Penditure LAA Exclusion System is indicated for the exclusion of the left atrial appendage of the heart, performed under direct visualization and in conjunction with other cardiac surgical procedures. Direct visualization, in this context, requires that the physician can see the heart directly, with or without assistance from a camera, endoscope, and so forth, or any other appropriate viewing technologies.
Contraindications:
• Do not use this device if the patient has a known allergy to nitinol (nickel titanium alloy).
• Do not use this device as a contraceptive tubal occlusion device.
Potential Adverse Effects:
Possible complications related to the use of Penditure™ LAA exclusion system in combination with open heart surgery are: bleeding, tissue damage, thromboembolism, and pericardial effusion. For a complete listing of all indications, contraindications, precautions, and warnings, please refer to the Instructions for Use, which accompany each product.
Only physicians who are trained in standard cardiac surgical procedures can use this device.
For more information, contact your local Medtronic cardiac surgery representative. U.S. Customer Service: 1-800-328-1357
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. For a listing of indications, contraindications, precautions, and warnings, please refer to the Instructions for Use.
Avalus™ Bioprosthesis
Indications: The Avalus bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
Contraindications: None known.
Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve replacement should use this device. Accelerated structural deterioration due to calcific degeneration of bioprosthesis may occur in: children, adolescents, young adults, and patients with altered calcium metabolism (e.g., chronic renal failure, or hyperparathyroidism). Adverse events can include: angina, cardiac dysrhythmias, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, infection other than endocarditis, transvalvular or paravalvular leak, myocardial infarction, nonstructural valve dysfunction (leaflet entrapment/impingement, obstructive pannus ingrowth, suture dehiscence, inappropriate sizing or positioning, or other), pericardial effusion or tamponade, prosthesis regurgitation, prosthesis stenosis, prosthesis thrombosis, stroke, structural valve deterioration (calcification, leaflet tear or perforation, or other), thromboembolism, tissue dehiscence, and transient ischemic attack. These complications could lead to reoperation, explant of the bioprosthesis, permanent disability, or death.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. For countries that use eIFUs, consult instructions for use at
medtronic.com/manuals.