Transcatheter Pulmonary Valve - Cardiac valve graft, animal-derived

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

Disponible des:

Medtronic Australasia Pty Ltd

clase:

Class I

Fabricat per:

Medtronic BV Earl Bakkenstraat 10, PJ Heerlen, 6422 Netherlands

Área terapéutica:

47471 - Cardiac valve graft, animal-derived

indicaciones terapéuticas:

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.

Estat d'Autorització:

A

Data d'autorització:

2011-07-18