HeartMate II Sealed Inflow Conduit - Implantable ventricular circulatory assist system inflow cannula, animal-derived
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
10-11-2017
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Available from:
Abbott Medical Australia Pty Ltd
Class:
Class III
Manufactured by:
Thoratec Corporation 6035 Stoneridge Drive, Pleasanton, CA, 94588 United States Of America
Therapeutic area:
61749 - Implantable ventricular circulatory assist system inflow cannula, animal-derived
Therapeutic indications:
The sealed inflow conduit of the pump is attached to the apex of the left ventricle and the pump sealed outflow graft is connected to the ascending aorta. The sealed inflow conduit and outflow elbows have a textured titanium microsphere surface. Intended as a component of a ventricular circulatory assist system for haemodynamic support to patients with end stage refactory left ventricular heart failure.
Authorization status:
Included
