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Promising data. Inspiring results.

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Edwards Lifesciences is committed to continued scientific advancement, and studies that investigate the safety and performance of new technologies.

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Learn more about the current methodologies, promising results and conclusions of the various RESILIA tissue studies below.

RESILIA tissue is building a track record of study data.

Start YearDescription
2010Juvenile sheep study
2011EU human feasibility study in Poland
2012Aortic/mitral COMMENCE IDE study

Pannus Formation Study

Influence of tissue technology on pannus formation on bioprosthetic heart valves1

The objective of this publication is to study the effect of RESILIA tissue on pannus formation.

Pannus Formation Study Clinical Summary

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pannus thumbnail
pannus thumbnail
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Methods

  • This publication reports the outcomes of two independent studies using a juvenile sheep model of mitral valve replacement with bovine pericardial tissue
    • In an 8-month study, valves with RESILIA tissue were compared to control valves with XenoLogiX treatment (XLX)
    • In a 5-month study, valves with RESILIA tissue were compared to control valves treated with the ThermaFix process (TFX)
  • Control valves were commercially available Carpentier-Edwards PERIMOUNT mitral valves, models 6900P, and 7000TFX. Test articles were the same models configured with RESILIA tissue
  • Explanted valves were examined macroscopically and histologically. Histological observations were made by an independent pathologist, blinded to group identity
  • Independent means of pannus quantification were employed in the two studies

For a more detailed overview of the Pannus Formation Study methodology and results please download the clinical summary.

Pannus Formation Study Clinical Summary

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pannus thumbnail
pannus thumbnail
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Juvenile Sheep Study

A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model2

The aim of the study was to assess the effects of RESILIA tissue technology on valve function and durability in a chronic sheep model. The model was designed to mirror the accelerated calcification seen in younger humans.

Juvenile Sheep Study Clinical Paper Details

Juvenile Sheep Study Clinical Paper
Juvenile Sheep Study Clinical Paper
Juvenile Sheep Study Clinical Paper
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Methods

  • 45 juvenile sheep were randomized and either a PERIMOUNT mitral valve (6900P, control group) or the same valve design incorporating the RESILIA tissue preservation technology (test group) was implanted in the mitral position
  • All valves were 25 mm
  • A transthoracic echocardiography was performed at 1 week and at 8 months postoperatively
  • Necropsy was performed at 8 months, and the valves were examined radiographically (soft tissue radiograph), histologically (hematoxylin and eosin and Von Kossa staining), and chemically (calcium content)

For a more detailed overview of the Juvenile Sheep Study methodology and results, please see link to clinical paper details.

Juvenile Sheep Study Clinical Paper Details

Juvenile Sheep Study Clinical Paper
Juvenile Sheep Study Clinical Paper
Juvenile Sheep Study Clinical Paper
View Details

EU Feasibility Study

5-year outcomes after aortic valve replacement with a novel RESILIA tissue bioprosthesis3

The EU Feasibility study investigated the safety and performance in AVR patients of a bioprosthesis with RESILIA tissue. Absence of structural valve deterioration (SVD) and stable transvalvular gradients were observed through 5 years.

EU Feasibility Study Clinical Summary

EU Feasibility Study
EU Feasibility Study
EU Feasibility Study
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Methods

  • Prospective, multicenter, single-arm, trial conducted at two sites
  • 133 patients underwent surgical AVR with an Edwards Pericardial Aortic Bioprosthesis with RESILIA tissue
    • Mean age 65.3 ± 13.5 years, with (26%) ≤ 60 years
    • 19 or 21 mm valve implanted in 43.6% of patients
  • Median follow up = 5 years; Total late follow-up time of 565.2 patient years (LPY)

For a more detailed overview of the EU Feasibility Study methodology and results please download the clinical summary.

EU Feasibility Study Clinical Summary

EU Feasibility Study
EU Feasibility Study
EU Feasibility Study
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COMMENCE Aortic Trial

Seven-year outcomes of the COMMENCE trial investigating aortic valve replacement with a novel tissue bioprosthesis4

The COMMENCE trial is an FDA pivotal trial designed to evaluate the safety and effectiveness of a bioprosthetic valve with the novel RESILIA tissue.

Methods

  • Prospective, multinational, multicenter (n = 27), single-arm, FDA Investigational Device Exemption trial

Full Cohort

  • Between January 2013 and March 2016, 689 patients underwent AVR with the Edwards Pericardial Aortic Bioprosthesis with RESILIA tissue (model 11000A)
    • Mean age 66.9 ± 11.6 years 
    • STS risk score 2.0 ± 1.8%
    • NYHA Class II and III were 50% and 24%, respectively 
  • A total of 512 patients completed 5-year follow up

Re-Consented Cohort

  • A total of 225 patients were re-consented for extended follow up
    • Mean age 65.1 ± 10.9 years
    • STS risk score 2.1 ± 2.1%
    • NYHA Class II and III were 43% and 19%, respectively 
  • A total of 195 patients completed 7-year follow up

For a more detailed overview of the COMMENCE trial methodology and results please download the clinical summary.

COMMENCE Aortic Trial 7-Year Clinical Summary

COMMENCE Trial Thumbnnail
COMMENCE Trial Thumbnnail
COMMENCE Trial Thumbnnail
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COMMENCE Aortic Trial 7-Year Clinical Summary

COMMENCE Trial Thumbnnail
COMMENCE Trial Thumbnnail
COMMENCE Trial Thumbnnail
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COMMENCE Trial Bicuspid Aortic Valve Sub-Analysis

Sub-analysis of COMMENCE aortic trial seven-year outcomes investigating safety outcomes and hemodynamics in patients with bicuspid aortic valves.5

Methods

  • Patients underwent echocardiograms annually through 7 years of follow up; these were evaluated by a core laboratory
  • All potential safety endpoints adjudicated by an independent Clinical Events Committee and independent echocardiographic core laboratory evaluated hemodynamic performance
  • SVD and other safety outcomes defined per "Guidelines for reporting morbidity and mortality after cardiac valve interventions" (Akins et al. 2008)

For a more detailed overview of the COMMENCE trial bicuspid aortic valve sub-analysis methodology and results, download the Infographic.

COMMENCE Trial Bicuspid Aortic Valve Sub-Analysis Infographic

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bicuspid aortic thumbnail
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COMMENCE Trial Bicuspid Aortic Valve Sub-Analysis Infographic

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bicuspid aortic thumbnail
bicuspid aortic thumbnail
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COMMENCE Trial Aortic Regurgitation Sub-Analysis

Sub-analysis of the five-year outcomes of the COMMENCE aortic trial investigating clinical and echocardiographic outcomes in patients with pure aortic stenosis compared to those with aortic regurgitation or mixed aortic valve disease6

Methods

  • Inclusion criteria involved patients with pure aortic regurgitation (AR) or mixed aortic valve disease (MAVD) defined as moderate or severe regurgitation at baseline with or without aortic stenosis (AS), and patients with pure AS, defined  as no regurgitation and mild, moderate, or severe stenosis at baseline
  • Evaluations included safety endpoints which were adjudicated by an independent clinical events committee, and hemodynamic performance which was evaluated by an independent echocardiographic core laboratory

For a more detailed overview of the COMMENCE trial five-year aortic regurgitation sub-analysis methodology and results, download the clinical summary.

COMMENCE Trial Aortic Regurgitation Sub-Analysis Clinical Summary

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bicuspid aortic thumbnail
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COMMENCE Trial Aortic Regurgitation Sub-Analysis Clinical Summary

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COMMENCE Mitral Trial

Mid-term outcomes of the COMMENCE trial investigating mitral valve replacement using a bioprosthesis with a novel tissue7

The COMMENCE trial is an ongoing prospective study to evaluate mitral valve replacement (MVR) using valves with RESILIA tissue.

COMMENCE Mitral Trial 5-Year Clinical Summary

commence mitral trial 5-year summary
commence mitral trial 5-year summary
commence mitral trial 5-year summary
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Methods

  • Prospective, multi-center (17 sites), single-arm, Investigational Device Exemption trial
  • 82 patients underwent MVR with the Edwards Pericardial Mitral Bioprosthesis with RESILIA tissue (model 11000M)
    • Median patient age was 70 years with 52.4% of patients aged 70 years or above
    • Median follow-up for the study cohort was 5.1 (1.4) years, with a total of 374.2 patient-years in aggregate
    • A total of 54 patients completed 5-year follow up

COMMENCE Mitral Trial 5-Year Clinical Summary

commence mitral trial 5-year summary
commence mitral trial 5-year summary
commence mitral trial 5-year summary
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Featured Products

Explore our current RESILIA tissue products

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INSPIRIS RESILIA aortic valve

KONECT RESILIA
KONECT RESILIA
KONECT RESILIA

KONECT RESILIA aortic valved conduit

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MITRIS RESILIA mitral valve

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References

  1. 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):418-25.
  2. Flameng W, Hermans H, Verbeken E, et al. A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model. J Thorac Cardiovasc Surg. 2015;14(9)340-5.
  3. Bartus K, Litwinowicz R, Bilewska A, et al. Final 5-year outcomes following aortic valve replacement with a RESILIA(TM) tissue bioprosthesis. Eur J Cardiothorac Surg. 2021;59(2):434-41.
  4. Beaver T, Bavaria JE, Griffith B, et al. Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis. J Thorac Cardiovasc Surg. 2024 Sep;168(3):781-791.
  5. Takayama H, Bavaria JE, Heimansohn DA, et al. RESILIA Tissue in Surgical Aortic Valve Replacement for Patients with Bicuspid Aortic Valves: Findings from a 7-year IDE study. Presented at the 60th Society of Thoracic Surgeons Annual Meeting, January 2024
  6. Thourani, VH, Puskas JD, Griffith B, et al. Five-year Comparison of Clinical and Echocardiographic Outcomes of Pure Aortic Stenosis with Pure Aortic Regurgitation or Mixed Aortic Valve Disease in the COMMENCE Trial. JTCVS Open. Sept (2024); https://doi.org/10.1016/j.xjon.2024.08.020.
  7. Heimansohn D, Baker C, Rodriguez E, et al. Mid-term outcomes of the COMMENCE trial investigating mitral valve replacement using a bioprosthesis with a novel tissue. JTCVS Open. Jun (2023);15:151-163.
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: Federal (USA) law restricts these devices to sale by or on the order of a physician. See instructions for use for full prescribing information.