Medtronic CoreValveTM Transcatheter Aortic Valve System

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

MEDTRONIC INTERNATIONAL, LTD.

Class:

Class D medical device

Manufactured by:

Medtronic CoreValve LLC

Therapeutic area:

Cardiovascular

Therapeutic indications:

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).

Product summary:

Device System Info:[System or Procedure Pack], [Sterile Medical Device], Sterile Medical Device; Models: Medtronic CoreValve Transcatheter Aortic Valve AOA - MCS-P3-26-AOA, Medtronic CoreValve Transcatheter Aortic Valve AOA - MCS-P3-29-AOA, Medtronic CoreValve Transcatheter Aortic Valve AOA - MCS-P3-31-AOA, Delivery Catheter System with AccuTrak™ Stability Layer - DCS-C4-18FR, Compression Loading System - CLS-3000-18FR

Authorization date:

2014-12-16