Medtronic CoreValveTM EvolutTM Transcatheter Aortic Valve System

Riik: Singapur

keel: inglise

Allikas: HSA (Health Sciences Authority)

Saadav alates:

MEDTRONIC INTERNATIONAL, LTD.

Klass:

Class D medical device

Valmistatud:

Medtronic CoreValve LLC

Terapeutiline ala:

Cardiovascular

Näidustused:

The Medtronic CoreValve™ system is indicated for use in patients with symptomatic heart disease due to either severe native calcific aortic stenosis or failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons operative risk score ≥8% or at a ≥15% risk of mortality at 30 days).

Toote kokkuvõte:

Device System Info:[System or Procedure Pack], [Sterile Medical Device], Sterile Medical Device; Models: Medtronic CoreValve™ Evolut™ Transcatheter Aortic Valve - MCS-P4-23- AOA, Delivery Catheter System with AccuTrak™ Stability Layer (23mm) - DCS-C4-18FR-23, Compression Loading System - CLS-3000-18FR

Loa andmise kuupäev:

2014-12-16