The INSPIRIS RESILIA aortic valve is the first offering in a new class of resilient bovine pericardial valves.
The INSPIRIS valve provides an ideal foundation for your patient’s future through:
1. RESILIA tissue
2. Trusted design and features
3. VFit technology¥
FOR MODEL 11500A SIZES 19–25 MM ONLY.
WARNING: DO NOT PERFORM STAND-ALONE BALLOON AORTIC VALVULOPLASTY PROCEDURES ON THIS VALVE FOR THE SIZES 19 – 25 mm. Although the valve will maintain a stable diameter at implant and during intracardiac conditions, the diameter of this valve will expand if radial force is applied, such as during a balloon aortic valvuloplasty. This may expand the valve causing aortic incompetence, coronary embolism or annular rupture.
Fluoroscopic representations of the size markers and the expansion zone are shown below.
WARNING: SIZE MARKER CORRESPONDS TO THE LABELED VALVE SIZE OF THE INSPIRIS VALVE AND IS NOT A REPLACEMENT FOR CURRENT SIZE IDENTIFICATION TECHNIQUES RECOMMENDED FOR USE IN TRANSCATHETER PROCEDURES.
The expansion zone is activated by applied radial force. Click video below to view the band expansion.
WARNING: Valve-in-valve sizing in the INSPIRIS valve has only been tested with specific Edwards transcatheter heart valves. Use of other transcatheter valves may result in embolization of transcatheter devices anchored within or result in annular rupture.
Refer to device instructions for use for full prescribing and safety information.
*These features have not been observed in clinical studies to establish the safety and effectiveness of the model 11500A for use in valve-in-valve procedures.
The INSPIRIS RESILIA Aortic Valve, Model 11500A, is intended for use as a heart valve replacement.
The INSPIRIS RESILIA Aortic Valve, Model 11500A, is indicated for the replacement of native or prosthetic aortic heart valves.
|11500A||INSPIRIS RESILIA aortic valve||19, 21, 23, 25, 27 & 29 mm|
|1133SET||Sizers - Complete Set||19,21,23,25,27, and 29 mm|
|1133||Sizers - Individual||19,21,23,25,27, and 29 mm|
|1126||Longer Single-Use Handle||N/A|
Please join Drs. Patrick McCarthy, Bart Meuris, and Douglas Johnston, for an educational webinar discussing the preclinical evaluation of RESILIA tissue and the clinical applications of the INSPIRIS RESILIA aortic valve.
What You and Your Loved Ones Should Know
The COMMENCE trial: Three-year outcomes with an aortic bioprosthesis with RESILIA tissue
We are committed to providing your institution, clinicians and staff with the highest levels of customer service and support to ensure seamless product implementation and ongoing use, including:
INSPIRIS RESILIA aortic valve
Indications: For use in replacement of native or prosthetic aortic heart valves.
Contraindications: There are no known contraindications with the use of the INSPIRIS RESILIA aortic valve.
Complications 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.
Warnings: DO NOT ADJUST THE VALVE DIAMETER BY EXPANDING THE BAND PRIOR TO/OR DURING IMPLANTATION OF THE SURGICAL VALVE. The expandable band is not designed to allow for compression or expansion during implantation of the surgical valve. This will cause damage to the valve and may result in aortic incompetence. 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. Valve-in-valve sizing in the INSPIRIS valve has only been tested with specific Edwards transcatheter heart valves. Use of other transcatheter valves may result in embolization of transcatheter devices anchored within or result in annular rupture.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information.
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