Medtronic CoreValve™ Evolut™ R 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:

Indicated for patients with severe symptomatic native aortic valve stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. Indicated for use in patients with symptomatic heart disease due to 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 predicted risk of operative mortality score ≥8% or at a ≥15% risk of mortality at 30 days). For patients presenting with severe native bicuspid aortic valve stenosis, CoreValve Evolut R system is indicated for patients who are at intermediate or greater risk for surgical aortic valve replacement (AVR) where intermediate risk is defined as Society of Thoracic Surgeons operative risk score of ≥4% or documented heart team agreement of risk for AVR due to frailty or comorbidities.

Toote kokkuvõte:

Device System Info:[Sterile Medical Device], TAV - liquid chemical sterilization DCS & LS - EO sterilization; Models: CoreValve™ Evolut™ R Transcatheter Aortic Valve - EVOLUTR-23, CoreValve™ Evolut™ R Transcatheter Aortic Valve - EVOLUTR-26, CoreValve™ Evolut™ R Transcatheter Aortic Valve - EVOLUTR-29, EnVeo™ R Loading System - LS-ENVEOR-23, EnVeo™ R Loading System - LS-ENVEOR-2629, EnVeo™ R Delivery Catheter System - ENVEOR-L, CoreValve™ Evolut™ R Transcatheter Aortic Valve - EVOLUTR-34, EnVeo™ R Loading System - LS-ENVEOR-34, EnVeo™ R Delivery Catheter System - ENVEOR-N

Loa andmise kuupäev:

2016-11-08