EDWARDS INTUITY Elite Valve System - Aortic heart valve bioprosthesis

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Beszerezhető a:

Edwards Lifesciences Pty Ltd

Osztály:

Class III

Gyártó:

Edwards Lifesciences LLC One Edwards Way, Irvine, California, 92614 United States Of America

Terápiás terület:

60242 - Aortic heart valve bioprosthesis

Terápiás javallatok:

The EDWARDS INTUITY Elite Valve System is an implantable surgical heart valve bioprosthesis, a delivery system and an inflation device. When used together as intended these system components allow minimally invasive surgical implantation of the EDWARDS INTUITY Elite heart valve into the native aortic annulus. The valve is indicated for patients whose aortic valvular disease is sufficiently advanced to warrant replacement of their native valve with a prosthetic valve.

Engedélyezési státusz:

A

Engedély dátuma:

2015-10-22