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See instructions for use for full prescribing information. Use of other transcatheter valves may result in embolization of transcatheter devices anchored within or result in annular rupture.ĬAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Valve-in-valve sizing in the INSPIRIS valve has only been tested with specific Edwards transcatheter heart valves. DO NOT PERFORM STAND-ALONE BALLOON AORTIC VALVULOPLASTY PROCEDURES ON THIS VALVE FOR THE SIZES 19 – 25 mm as this may expand the valve causing aortic incompetence, coronary embolism or annular rupture. This will cause damage to the valve and may result in aortic incompetence. The expandable band is not designed to allow for compression or expansion during implantation of the surgical valve. Warnings: DO NOT ADJUST THE VALVE DIAMETER BY EXPANDING THE BAND PRIOR TO/OR DURING IMPLANTATION OF THE SURGICAL VALVE. Indications: For use in replacement of native or prosthetic aortic heart valves.Ĭontraindications: There are no known contraindications with the use of the INSPIRIS RESILIA aortic valve.Ĭomplications and Side Effects: Thromboembolism, valve thrombosis, hemorrhage, hemolysis, regurgitation, endocarditis, structural valve deterioration, nonstructural dysfunction, stenosis, arrhythmia, transient ischemic attack/stroke, congestive heart failure, myocardial infarction, any of which could lead to reoperation, explantation, permanent disability, and death. Complications of Bioprosthetic Valve Fracture as an Adjunct to Valve-in-Valve TAVR, Structural Heart, 2019 3:2, 92-99. Bioprosthetic Valve Fracture During Valve-in-valve TAVR: Bench to Bedside. Presented at Heart Valve Society 2019 Annual Meeting. Five-year Outcomes of Aortic Valve Replacement Using a Bioprosthetic Valve with the Novel RESILIA Tissue: Final Study Results. Bartus K, Bilewska A, Bochenek M, et al. #Inspire 6kg eco valve trialFive-year Outcomes of the COMMENCE Trial Investigating Aortic Valve Replacement with RESILIA Tissue.
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