*RESILIA tissue tested against tissue from commercially available pericardial valves from Edwards in a juvenile sheep model1. No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.
RESILIA tissue

Patients are living longer than ever before - and they want to live their longer lives to the fullest, continuing to enjoy their active lifestyles.

The primary mode of failure for bovine pericardial valves is calcification. During tissue fixation and storage, tissue is exposed to free aldehydes; in vivo, calcium binds to free aldehydes.

RESILIA tissue is bovine pericardial tissue transformed by a novel integrity preservation technology.

RESILIA tissue valves have been subjected to a rigorous development program over 12 years. It involved more than 100 evaluations of safety and efficacy, including a large, first-of-its-kind 8-month juvenile sheep study.1

RESILIA tissue valves have been subjected to a rigorous development program over 12 years. It involved more than 100 evaluations of safety and efficacy, including a large, first-of-its-kind 8-month juvenile sheep study1.

Over 800 patients have received a valve with RESILIA tissue. Early results established the safety and effectiveness of valves with RESILIA tissue in patients undergoing surgical aortic valve replacement.**

The primary mode of failure for bovine pericardial valves is calcification. During tissue fixation and storage, tissue is exposed to free aldehydes; in vivo, calcium binds to free aldehydes.

RESILIA tissue is bovine pericardial tissue transformed by a novel integrity preservation technology.

RESILIA tissue valves have been subjected to a rigorous development program over 12 years. It involved more than 100 evaluations of safety and efficacy, including a large, first-of-its-kind 8-month juvenile sheep study.1

RESILIA tissue valves have been subjected to a rigorous development program over 12 years. It involved more than 100 evaluations of safety and efficacy, including a large, first-of-its-kind 8-month juvenile sheep study1.

Over 800 patients have received a valve with RESILIA tissue. Early results established the safety and effectiveness of valves with RESILIA tissue in patients undergoing surgical aortic valve replacement.**

**RESILIA tissue tested against tissue from commercially available pericardial valves from Edwards in a juvenile sheep model1.
No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.

References
  1. Flameng W, et al. A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model.
    J Thorac Cardiovasc Surg. 2015;149:340–5
  2. US Social Security Administration 1900-2100 Actuarial Study No. 120: 2005 (S-1598).
INSPIRIS valve

The INSPIRIS RESILIA aortic valve is the first offering in a new class of resilient tissue 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¥

The INSPIRIS RESILIA aortic valve is the first offering in a new class of resilient tissue valves.

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¥

The INSPIRIS RESILIA aortic valve is the first offering in a new class of resilient tissue valves.

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¥

INSPIRIS RESILIA aortic valve

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.

VFit technology incorporates two novel features designed for potential future valve-in-valve (ViV) procedures:*
  • fluoroscopically visible size markers
  • an expansion zone

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 procedures in an INSPIRIS valve should be performed according to the combinations in the SAPIEN XT IFU. Other combinations have not been evaluated and may result in the 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.

Intended use and indications for use

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.

Materials List

  • Valve leaflets: Bovine pericardium
  • Stent: Cobalt-chromium alloy, polyester
  • Fabric covering stent: Polyester cloth
  • Valve sewing ring: Silicone rubber

Tissue Platform

  • Model 11500A features RESILIA tissue, bovine pericardial tissue transformed by a novel integrity preservation technology, which incorporates two new proprietary features that, effectively eliminate free aldehydes while protecting and preserving the tissue

General Product Information

  • Storage temperature: 10°C to 25°C
  • Storage: Dry storage
  • Rinse procedure: None required, ready for use
  • VFit technology: Expansion zone and fluoroscopically visible size marker on sizes 19–25 mm¥
ModelDescriptionSizesImage
11500A INSPIRIS RESILIA aortic valve 19, 21, 23, 25, 27 & 29 mm
ModelDescriptionSizes
1133SET Sizers - Complete Set 19,21,23,25,27, and 29 mm
1133 Sizers - Individual 19,21,23,25,27, and 29 mm
TRAY1133 Accessory Tray N/A
1111 Reusable Handle N/A
1126 Longer Single-Use Handle N/A
¥Refer to device instructions for use for important warnings related to VFit technology. 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. VFit technology is available on sizes 19-25 mm.

**No rinse required.

References
  1. Flameng W, et al. A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model.
    J Thorac Cardiovasc Surg. 2015;149:340–5.
  2. Bourguignon T, et al. Very long-term outcomes of the Carpentier-Edwards Perimount valve in aortic position.
    Ann Thorac Surg. 2015;99:831–7.
  3. Johnston DR, et al. Long-term durability of bioprosthetic aortic valves: implications from 12,569 implants.
    Ann Thorac Surg. 2015;99:123947.
  4. Forcillo J, et al. Carpentier-Edwards pericardial valve in the aortic position: 25-years experience. Ann Thorac Surg.
    2013;96:48693.
Resources

SAPIEN 3 valve patient brochure

INSPIRIS Patient Brochure

What You and Your Loved Ones Should Know

Download brochure (PDF)

SAPIEN 3 valve intermediate-risk data brochure

COMMENCE Trial Clinical Summary

The COMMENCE trial: Two-year outcomes with an aortic bioprosthesis with RESILIA tissue

Download brochure (PDF)


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 tech_support@edwards.com anytime, day or night
  • Customer service – Call 800-424-3278 to speak to a customer service representative

Contact a sales representative

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 procedures in an INSPIRIS valve should be performed according to the combinations in the SAPIEN XT IFU. Other combinations have not been evaluated and may result in the 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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