Transcatheter Aortic Valve - India CDSCO Medical Device Registration

Product Information

The CoreValve Evolut PRO system is indicated for patients presenting with severe native aortic valve stenosis. For patients presenting with severe native bicuspid aortic valve stenosis, the CoreValve Evolut PRO system is indicated for patients who are at intermediate or greater risk for surgical aortic valve replacement (CoreValve Evolut Pro) where intermediate risk is defined as Society of Thoracic Surgeons operative risk score ≥4% or documented heart team agreement of risk for AVR due to frailty or comorbidities. For patients presenting at low risk for AVR (CoreValve Evolut Pro), the system is indicated for patients ≥ 70 years of age with an LVEF >30%. The CoreValve Evolut PRO system is also indicated for patients with a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement who are at high or greater risk for surgical aortic valve replacement (CoreValve Evolut Pro) where high risk is defined as Society of Thoracic Surgeons operative risk score ≥ 8% or documented heart team agreement of risk for AVR due to frailty or comorbidities.