RESILIENT VALVES

RESILIENT VALVES

*RESILIA tissue tested against tissue from commercially available pericardial valves from Edwards in a juvenile sheep model 1. 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 12-year development program involving more than 100 evaluations of safety and efficacy, including a large, first-of-its-kind 8-month juvenile sheep study.1

Over 800 patients have received a valve with RESILIA tissue in either the aortic, mitral or pulmonary position.

*RESILIA tissue tested against tissue from commercially available pericardial valves from Edwards in a juvenile sheep model 1.
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. World Health Organization. World Health Statistics 2014. Geneva, Switzerland: WHO; 2014. WHO/HIS/HSI/14.1
  3. Bourguignon T, et al. Very long-term outcomes of the Carpentier-Edwards Perimount valve in aortic position. Ann Thorac Surg. 2015;99:831-7
  4. Johnston DR, et al. Long-term durability of bioprosthetic aortic valves: implications from 12,569 implants. Ann Thorac Surg. 2015;99:1239-47.
  5. Forcillo J, et al. Carpentier-Edwards pericardial valve in the aortic position: 25-years experience. Ann Thorac Surg. 2013;96:486–93.
Inspiris Valve

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 bovine pericardial 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 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 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

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 patients who require replacement of their native or prosthetic aortic valve.

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, virtually 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. World Health Organization. World Health Statistics 2014. Geneva, Switzerland: WHO; 2014. WHO/HIS/HSI/14.1
  3. Bourguignon T, et al. Very long-term outcomes of the Carpentier-Edwards Perimount valve in aortic position. Ann Thorac Surg. 2015;99:831-7
  4. Johnston DR, et al. Long-term durability of bioprosthetic aortic valves: implications from 12,569 implants. Ann Thorac Surg. 2015;99:1239-47.
  5. Forcillo J, et al. Carpentier-Edwards pericardial valve in the aortic position: 25-years experience. Ann Thorac Surg. 2013;96:486–93.

For professional use.

For professional use.

For professional use. See instructions for use for full prescribing information including indications, contra-indications, warnings, precautions and adverse events.

Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity.

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