A future of possibility. That's what RESILIA tissue brings.
Surgical heart valves with RESILIA tissue offer active patients a way to think differently about life after surgery. Choosing a RESILIA tissue valve means a life of possibility: an active life.
- A life free from ongoing anticoagulant therapy and the associated dietary and lifestyle restrictions that come with mechanical valves
- A life with the potential to avoid future open heart surgery
- A life of confidence in what's to come
Evidence of RESILIA tissue performance
A key challenge with pericardial tissue is structural valve deterioration (SVD), much of which is due to calcium buildup. RESILIA tissue is transformed to resist calcification differently.
For more clinical information on the performance of RESILIA tissue, visit the Inspiring Results page.
COMMENCE aortic clinical trial
Clinically stable hemodynamics and zero structural valve deterioration (SVD) through 5 years (in 689 patients)
through 5 years*
Preclinical juvenile sheep model study
Significant improvement of anti-calcification properties in test valves compared to control.1
after 8 months**
- *1 SVD diagnosed at Post-operative 1848.
- ** RESILIA tissue tested against tissue from commercially available bovine pericardial valves from Edwards in a juvenile sheep model. Flameng, et al.J Thorac Cardiovasc Surg 2015;149:340-5
For surgeons, a difference that offers more options
For patients referred for surgical valve replacement, there are now three options: mechanical valves, conventional tissue valves or RESILIA tissue valves. RESILIA tissue gives surgeons the freedom to offer a resilient tissue alternative that brings the quality-of-life benefits of tissue valves to patients.
Together, charting the future of surgical valves
With RESILIA tissue, patients and surgeons alike gain the freedom that comes with peace of mind. It’s knowing that Edwards Lifesciences has a proven commitment to ongoing innovation in surgical structural heart solutions, to advance the state of the art and put better outcomes within reach.
Today’s RESILIA tissue portfolio is the culmination of years of careful, deliberate development in collaboration with cardiac surgeons, innovating while building on proven technology. It represents the best of creative scientific minds coming together to address unmet needs and satisfy patient demands for better surgical options.
The Edwards Advantage
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:
- 24/7 technical support – Simply call 800-822-9837 or email email@example.com anytime, day or night
- Customer service – Call 800-424-3278 to speak to a customer service representative
Contact a sales representative
- Flameng W, et al. A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model. J Thorac Cardiovac Surg. 2015; 149:340-5.
- Priev A, et al. Glycerol decreases the volume and compressibility of protein interior. Biochemistry. 1996;35(7):2061 2066.
Important Safety Information
RESILIA Tissue Devices
Indications: INSPIRIS RESILIA Aortic Valve - For use in replacement of native or prosthetic aortic heart valves. KONECT RESILIA Aortic Valved Conduit - For use in replacement of native or prosthetic aortic heart valves and the associated repair or replacement of a damaged or diseased ascending aorta.
Contraindications: There are no known contraindications with the use of these RESILIA tissue heart valve devices.
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. Additional adverse events potentially associated with the use of polyester vascular grafts in the KONECT RESILIA AVC include hemorrhage, thrombosis, graft infection, embolism, aneurysm, pseudoaneurysm, seroma, occlusion (anastomotic intimal hyperplasia), immunological reaction to collagen (shown to be a weak immunogen; infrequent, mild, localized and self-limiting), intimal peel formation, and conduit dilatation.
Warnings: INSPIRIS RESILIA Aortic Valve - 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 these devices to sale by or on the order of a physician. See instructions for use for full prescribing information.
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