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KONECT RESILIA aortic valved conduit

Konect resilia
Konect resilia
Konect resilia
KONECT RESILIA
KONECT RESILIA
KONECT RESILIA

First pre-assembled, ready-to-implant valved conduit with RESILIA tissue.

As the next offering in Edwards Lifesciences’ class of resilient bovine pericardial valves, ready-to-implant KONECT RESILIA aortic valved conduit helps patients maintain their active lifestyles and reduces the complexity of bio-Bentall procedures.*

RESILIA Tissue

Edwards' integrity preservation technology transforms bovine pericardial tissue into RESILIA tissue, effectively eliminating free aldehydes, while protecting and preserving the tissue.

RESILIA tissue is the first to deliver the combination of:

resilia tissue features
resilia tissue features
resilia tissue features

A Proven Heritage

KONECT RESILIA aortic valved conduit is built on the proven performance of both the Carpentier–Edwards PERIMOUNT valve platform and the Gelweave Valsalva graft.

valve platform
valve platform
valve platform

Valve platform

Proven performance of the PERIMOUNT valve design—a design with published clinical durability of over 20 years2-4

gelweave valsalva graft
gelweave valsalva graft
gelweave valsalva graft

Gelweave Valsalva graft

The world’s first anatomically designed aortic root graft with over 15 years of aortic root surgery clinical experience5,6

Ready to implant

The pre-assembled KONECT RESILIA aortic valved conduit intuitively eliminates procedural steps§, which is especially important in emergency cases.

ready to implant 1
ready to implant 1
ready to implant 1

Edwards’ quality-controlled pre-assembly of valve and Gelweave Valsalva graft provides a consistent and reliable hemostatic connection

ready to implant 2
ready to implant 2
ready to implant 2

Pre-mounted to an easy-access, single-cut release holder

* By eliminating procedure steps.
† RESILIA tissue tested against commercially available bovine pericardial tissue from Edwards in a juvenile sheep model.1
No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.
‡ Consult instructions for use for device preparation instructions.
§ As compared to self-assembled tissue valved conduits.

Life R Icon
Life R Icon
Life R Icon

A promise of freedom.

That's the power of RESILIA tissue.

lady earphones
lady earphones
lady earphones
lady earphones
lady earphones
lady earphones

Specifications

Intended use and indications for use

The KONECT RESILIA AVC, Model 11060A, is intended for use as a replacement for the aortic heart valve and the ascending aorta.

The KONECT RESILIA AVC, Model 11060A, is indicated for patients who require replacement of their native or prosthetic aortic valve, and the associated repair or replacement of a damaged or diseased ascending aorta.

The KONECT RESILIA AVC, Model 11060A, should only be used with the dedicated sizers that replicate the DualFit sewing ring (Model 1190 Sizers and Tray).

Materials list

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

Tissue Platform

  • Model 11060A features RESILIA tissue, bovine pericardial tissue transformed by a novel integrity preservation technology, which incorporates two 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: Immerse device in sterile saline for 5 minutes

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

800-822-9837

For product information and orders

800-424-3278
Mitral Replacement Valves
Mitral Replacement Valves
Mitral Replacement Valves

Contact a sales representative

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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;99:1239–47.
  4. Forcillo J, et al. Carpentier-Edwards pericardial valve in the aortic position: 25-years experience. Ann Thorac Surg. 2013;96:486–93.
  5. De Paulis R, et al. A new aortic Dacron conduit for surgical treatment of aortic root pathology. Ital Heart J. 2000;1(7):457-63.
  6. De Paulis R, et al. Long-term results of the valve reimplantation technique using a graft with sinuses. J Thorac Cardiovasc Surg. 2016;151:112-9.

Important safety information

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.