Skip to main content
Edwards Lifesciences Logo

Supporting your discussions

Supporting your discussions
Supporting your discussions
Supporting your discussions

Resources

When it's time for a heart-to-heart conversation with your surgical valve patients, consider these tools to help get the dialogue going.

INSPIRIS-RESILIA aortic valve
INSPIRIS-RESILIA aortic valve
INSPIRIS-RESILIA aortic valve

INSPIRIS RESILIA aortic valve

Informed Discussion Guide
Informed Discussion Guide
Informed Discussion Guide

Informed Discussion Guide: Surgical aortic valve replacement

KONECT RESILIA aortic valved conduit
KONECT RESILIA aortic valved conduit
KONECT RESILIA aortic valved conduit

KONECT RESILIA aortic valved conduit

Inspiring Results RESILIA Tissue Clinical Data Page
Inspiring Results RESILIA Tissue Clinical Data Page
Inspiring Results RESILIA Tissue Clinical Data Page

Inspiring Results RESILIA Tissue Clinical Data Page

MITRIS RESILIA aortic valve
MITRIS RESILIA aortic valve
MITRIS RESILIA aortic valve

MITRIS RESILIA aortic valve

Timely Intervention Fact Sheet
Timely Intervention Fact Sheet
Timely Intervention Fact Sheet

Timely Intervention Fact Sheet

Anticoagulation Considerations for Choosing a Tissue or Mechanical Heart Valve
Anticoagulation Considerations for Choosing a Tissue or Mechanical Heart Valve
Anticoagulation Considerations for Choosing a Tissue or Mechanical Heart Valve

Anticoagulation Considerations for Choosing a Tissue or Mechanical Heart Valve

Aortic Regurgitation Website
Aortic Regurgitation Website
Aortic Regurgitation Website

Aortic Regurgitation Website

PP--US-7494-Transcatheter-aortic-valve-with-RESILIA-tissue-704x480
PP--US-7494-Transcatheter-aortic-valve-with-RESILIA-tissue-704x480
PP--US-7494-Transcatheter-aortic-valve-with-RESILIA-tissue-704x480

Transcatheter aortic valve with RESILIA tissue

Surgical Heart Valve Replacement in Women of Childbearing Age
Surgical Heart Valve Replacement in Women of Childbearing Age
Surgical Heart Valve Replacement in Women of Childbearing Age

Surgical Heart Valve Replacement in Women of Childbearing Age

PDF thumbnail
PDF thumbnail
PDF thumbnail

Surgical Tissue Valve Guide for Your Patients

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.