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EU Feasibility Study
Results at 5 years
A prospective, multicenter, single-arm trial of 133 patients who underwent surgical aortic valve replacement (SAVR).1
83.4%
Freedom from all-cause mortality
99.2%
Freedom from valve thrombosis
For more details, download the clinical summary.
Explore the clinical data
The RESILIA tissue valve demonstrated a good safety profile and excellent hemodynamic performance over 5 years of follow-up.
Preclinical Study: Pannus Formation Animal Studies
Results of 2 animal studies
Two independent studies, a 5-month study and an 8-month study, using a juvenile sheep model of mitral valve replacement with bovine pericardial tissue.2
Five-month study results
1.44 ± 1.52 mm²
pannus growth vs 2.61 ± 2.15 mm2
Eight-month study results
0.095 ± 0.049 mm²
pannus growth vs 0.134 ± 0.066 mm2
RESILIA tissue valves were associated with reduced pannus formation vs control valves, demonstrating the potential to improve long-term outcomes for patients.
Preclinical Study: Juvenile Sheep Study
Results
Forty-five juvenile sheep were randomized to assess an advanced tissue preservation technology. Of these, 31 survived for treatment evaluation (17 RESILIA tissue, 14 control valves with XenoLogiX treatment). Echocardiography at 1 week showed normal valve function in both groups. At 8 months, cardiac output increased significantly to the same extent in both groups (vs baseline; P <.01). The mean transvalvular pressure gradient also increased, but significantly more in the control group compared with the test group (P=.03).3
1.9 ± 0.3 μg/mg
calcium content vs 6.8 ± 1.6 μg/mg
For more details, download the clinical paper
A = PERIMOUNT Tissue Valve
B = RESILIA Tissue Valve
This novel tissue preservation technology, when applied to the PERIMOUNT mitral valve, significantly improved hemodynamic and anti-calcification properties vs the standard PERIMOUNT valve.
References
- Bartus K, Litwinowicz R, Bilewska A, et al. Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis. Eur J Cardiothorac Surg. 2021;59(2):434-441. doi:10.1093/ejcts/ezaa311
- Tod TJ, Gohres RA, Torky M, et al. Influence of Tissue Technology on Pannus Formation on Bioprosthetic Heart Valves. Cardiovasc Eng Technol. 2021;12(4):418-425. doi:10.1007/s13239-021-00530-1
- Flameng W, Hermans H, Verbeken E, Meuris B. A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model. J Thorac Cardiovasc Surg. 2015;149(1):340-345. doi:10.1016/j.jtcvs.2014.09.062
Important Safety Information
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. MITRIS RESILIA Mitral Valve - For use in replacement of native or prosthetic mitral heart valves.
Contraindications: There are no known contraindications with the use of these RESILIA tissue heart valve devices.
Complications and Side Effects: INSPIRIS RESILIA Aortic Valve: 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. MITRIS RESILIA Mitral Valve - Thromboembolism, valve thrombosis, hemorrhage, hemolysis, regurgitation, endocarditis, structural valve deterioration, nonstructural dysfunction, stenosis, arrhythmia, transient ischemic attack/stroke, congestive heart failure, myocardial infarction, ventricular perforation by stent posts, any of which could lead to reoperation, explantation, permanent disability, and death.
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: US law restricts these devices to sale by or on the order of a physician. See instructions for use for full prescribing information.