Transcatheter Pulmonary Valve - Cardiac valve graft, animal-derived

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Verfügbar ab:

Medtronic Australasia Pty Ltd

Klasse:

Class I

Hergestellt von:

Medtronic BV Earl Bakkenstraat 10, PJ Heerlen, 6422 Netherlands

Therapiebereich:

47471 - Cardiac valve graft, animal-derived

Anwendungsgebiete:

The Melody Transcatheter Pulmonary Valve is indicated for use in patients with the following clinical consitions: - Patients with regurgitant prosthetic Right Ventricular Outflow Tract (RVOT) conduits with a clinical indication for invasive or surgical internention, OR - Patients with stenotic prosthetic RVOT conduits where the risk of worsening regurgitation is a relative contrindication to balloon dilatation or stenting. - Existence of a full (circumferential) RVOT conduit that was equal or greater than 16mm in diameter when originally implanted. The delivery system is a balloon-in-balloon catheter with a retractable sheath.

Berechtigungsstatus:

A

Berechtigungsdatum:

2011-07-18