Indications, Safety and Warnings
Caution: Federal law (USA) restricts these devices 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.
Bio-Medicus® Cannula
Indications: This percutaneous cannula is for use by trained physicians only, to cannulate vessels, perfuse vessels or organs in a patient for cardiopulmonary bypass circulation. Standard surgical or percutaneous insertion techniques can be employed. This product is intended for use up to six hours or less.
Contraindications: Alone, this cannula is not a medical treatment device. Selection of patient as a candidate for such procedures is the physicians’ responsibility. The outcome is dependent on many variables including patient pathology, surgical procedure, and perfusion procedures. Do not use if the patient has severe peripheral atherosclerosis or severe arterial dissection. This device is not intended for use except as indicated.
Mosaic® Porcine Bioprosthesis
Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves.
Contraindications: This device is not intended for use except as indicated. Warnings/Precautions/Adverse Events: Accelerated 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, hyperparathyroidism). Adverse events can include: angina, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis.
