Transcatheter Aortic Valve
- UID
- IMP/MD/2019/000355_48fe5c68e995038f500d4fd410b1353a_53d8bd481e8e1e8ae3cf00cb8d8321cf
- Device class
- Class D
- Brand name
- CoreValve Evolut Pro
- Approving authority
- CDSCO
- 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.
Transcatheter Aortic Valve is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000355_48fe5c68e995038f500d4fd410b1353a_53d8bd481e8e1e8ae3cf00cb8d8321cf. This device is marketed under the brand name CoreValve Evolut Pro. The license holder is India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India, and it is classified as Device Class Class D. The approving authority is CDSCO.
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