Medtronic CoreValve™ Evolut™ PRO 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:

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 PRO 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.

Product summary:

Device System Info:[Sterile Medical Device], Liquid chemical sterilization EtO sterilization; Models: CoreValve™ Evolut™ PRO Transcatheter Aortic Valve - EVOLUTPRO-23, CoreValve™ Evolut™ PRO Transcatheter Aortic Valve - EVOLUTPRO-26, CoreValve™ Evolut™ PRO Transcatheter Aortic Valve - EVOLUTPRO-29, EnVeo™ R Delivery Catheter System - ENVEOR-N, EnVeo™ R Loading System - LS-MDT2-23, EnVeo™ R Loading System - LS-MDT2-2629

Authorization date:

2019-02-12