The research we do today inspires the procedures you will perform tomorrow. That’s why we’re committed to continued scientific advancement, and studies that investigate the safety and performance of new technologies.

COMMENCE trial video

Our trials aim to build upon one another by adding new variables which further challenge valve safety and efficacy. Our COMMENCE trial increased the patient population from the EU Feasibility trial, and the RESILIENCE trial is designed to look at different outcome measures to help further establish long-term valve durability.

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

RESILIA tissue is building a track record of study data that now spans more than a decade

YearDescription
2010 Juvenile sheep study
2011 EU human feasibility study in Poland
2012 US aortic/mitral COMMENCE IDE study
2017 INSPIRIS RESILIA valve approved by FDA
2018 RESILIENCE study begins
2026 COMMENCE study 10-year follow up
2027 RESILIENCE study 11-year follow up
Juvenile Sheep Study

Juvenile Sheep Study

A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model4

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, a key target for RESILIA tissue valves.

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)

Results

  • 31 animals (14 controls and 17 test animals) remained in perfect condition during the 8-month follow-up period
  • 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)
  • Flow turbulence across the prosthesis was increased in the control valves compared with the test valves. The test valves had significantly less calcium content than the controls (1.9 ± 0.3 vs 6.8 ± 1.6 μg/mg; P = .002). This was confirmed by radiographic analysis and histology (see images below)
A = PERIMOUNT Tissue Valve
PERIMOUNT Tissue Valve
B = RESILIA Tissue Valve
RESILIA Tissue Valve

No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.

Conclusions

This study demonstrates that the novel tissue preservation technology, when applied to the PERIMOUNT mitral valve, significantly improves hemodynamic and anti-calcification properties compared with the standard PERIMOUNT valve.

For a more detailed overview of the Juvenile Sheet Study methodology and results, please see link to clinical paper.
Juvenile Sheep Study Clinical Paper Details
EU Feasibility Study

EU Feasibility Study

5-year outcomes after aortic valve replacement with a novel RESILIA tissue bioprosthesis1

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.

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)

Results

  • Safety events
    • No cases of SVD 0%/LPY
    • Late all-cause mortality 3.2%/LPY
    • Late valve thrombosis 0.2%/LPY
    • Late endocarditis 0.2%/LPY
    • Late major paravalvular leak 0.0%/LPY
  • Stable hemodynamic performance observed at 5 years
    • Mean gradient was 14.8 ± 7.6 mmHg
    • Average EOA was 1.4 ± 0.5 cm2

Conclusions

The RESILIA tissue valve demonstrated excellent hemodynamic performance and safety outcomes over 5 years of follow-up.

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 Clinical Summary
COMMENCE Trial

COMMENCE Trial

Four-year outcomes of aortic valve replacement with a bioprosthetic valve with a novel tissue2

The objective of the COMMENCE trial is to evaluate the safety and effectiveness of a bioprosthetic valve with the novel RESILIA tissue. Absence of structural valve deterioration (SVD) and valve thrombosis, stable transvalvular gradients, and freedom from transvalvular regurgitation were observed at 4 years. A subset of patients will be observed at 10 years.

Methods

  • Prospective, multinational, multicenter (n = 27), single-arm, FDA Investigational Device Exemption trial
  • 689 patients underwent surgical AVR with the Edwards Pericardial Aortic Bioprosthesis with RESILIA tissue (model 11000A)
    • Mean age 67.0 ± 11.6 years, with 140 patients (21%) under 60 years
    • 71.8% male
    • 26% NYHA Class III/IV
    • Mean STS PROM 2.0 ± 1.8%
    • 59% isolated AVR
  • 2,533 aggregate patient-years of follow up
    • Median follow up = 4 years

Results

  • Safety events
    • No cases of SVD or valve thrombosis
    • Late all-cause mortality 2.2%/late patient years (LPY)
    • Late major paravalvular leak was 0.1%/LPY
    • Late endocarditis 0.5%/LPY
  • Improved hemodynamic performance compared to baseline was observed through 4 years:
    • Mean gradient was 10.2 ± 4.6 at 1 year, 10.2 ± 4.5 at 2 years, and 10.8 ± 6.0 at 3 years, and 11.0 ± 5.6 mmHg at 4 years
  • At 4 years:
    • 91.9% freedom from death
    • 98.6% freedom from re-operation

Conclusions

  • Favorable safety profile and stable hemodynamics of RESILIA tissue in a bovine aortic valve
  • Absence of SVD, increased gradients, and regurgitation support durability at 4 years.
  • Follow-up continues on the long-term safety and effectiveness of this new tissue
For a more detailed overview of the COMMENCE Trial methodology and results please download the Clinical Summary.

COMMENCE Trial Clinical Summary

COMMENCE Trial Clinical Summary
RESILIENCE Study Design

RESILIENCE Study Design

Study Design of the Prospective Non-Randomized Single Arm Multicenter Evaluation of the Durability of Aortic Bioprosthetic Valves with RESILIA Tissue in Subjects under 65 Years Old (RESILIENCE Trial)3

The objective of the RESILIENCE trial is to determine the time to valve failure due to valve deterioration requiring re-intervention, as well as to collect/investigate early potential predictors of valve durability (e.g. calcification and hemodynamic deterioration) in RESILIA tissue. The RESILIENCE trial is the first prospective study to associate both clinical and imaging definitions of SVD with long-term (11 years) bioprosthetic valve durability.

Methods

  • Multicenter, prospective, non-randomized, single-arm, observational trial
  • Up to 250 patients who previously underwent SAVR with a RESILIA tissue valve will be enrolled at up to 15 investigational centers across the United States and Europe
    • Includes patients <65 years old; at time of implant this is a population that is at high risk to develop SVD
    • First patient enrolled on November 21, 2018
    • Anticipated 3 year enrollment period
  • Patients undergo a TTE and non-contrast CT at 5, 7, 9, and 11 years post-valve implant (Figure 1).
    View Figure 1
  • The definition proposed by Dvir et al. includes four stages: Stage 0: no SVD; Stage 1: Morphological SVD; Stage 2: Moderate hemodynamic SVD; and Stage 3: Severe hemodynamic SVD

Echocardiography and CT Core Laboratories will be responsible for independently evaluating TTEs and CTs submitted by trial sites and will report upon the primary and secondary outcomes of the trial.

  • The morphology and mobility of the bioprosthetic valve leaflets will be visually assessed in multiple views by 2D echocardiography
  • Non-contrast CT images will be acquired using a 64 slice or dual-source scanner
    • Valve leaflet calcification will be measured by the volumetric method that identifies calcium within the valve leaflets
    • The total volume of calcification over the 3 valve leaflets will be calculated and expressed in mm3

The RESILIENCE trial will be the first prospective study that uses both clinical and imaging definitions of SVD to provide a comprehensive description of all stages of SVD and determine the long-term (11 years) durability of the RESILIA tissue in a aortic valve.

For a more detailed overview of the RESILIENCE study methodology, please download the clinical summary.

RESILIENCE Study Design Clinical Summary

RESILIENCE Study Design Clinical Summary
Featured Products

Featured Products

Explore our current RESILIA tissue products

INSPIRIS RESILIA aortic valve

INSPIRIS RESILIA aortic valve

Learn more
KONECT RESILIA aortic valved conduit

KONECT RESILIA aortic valved conduit

Learn more

Contact us

References:

  1. Bartus K et al., Eur J Cardiothorac Surg. 2020; doi:10.1093/ejcts/ezaa311
  2. Johnston DR, et al. J Thorac Cardiovasc Surg. 2020. doi.org/10.1016/j.jtcvs.2020.01.095
  3. Pibarot P, et al. Structural Heart. 2020;4(1):46-52.
  4. Flameng W, et al. J Thorac Cardiovasc Surg. 2015;149:340–5.

Important Safety Information

Important Safety Information

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.

KONECT RESILIA Aortic Valved Conduit

Indications: 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 the KONECT RESILIA aortic valved conduit.

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. Adverse events potentially associated with the use of polyester vascular grafts 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.

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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