BIOTRONIK ORSIRO MISSION SIROLIMUS ELUTING CORONARY STENT SYSTEM - HSA Registration DE0505711
Access comprehensive regulatory information for BIOTRONIK ORSIRO MISSION SIROLIMUS ELUTING CORONARY STENT SYSTEM in the Singapore medical device market through Pure Global AI's free database. This CLASS COM medical device is registered under HSA registration number DE0505711 and owned by Biotronik AG. The device was registered on April 26, 2021.
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is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de-novo stenotic lesions and in-stent restenotic lesions (length ≤ 40mm) in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm including the following patient and lesion subsets: Acute Coronary Syndrome (ACS);ST-Elevation Myocardial Infarction (STEMI); Diabetes Mellitus (DM); Complex Lesions (B2/C); High Bleeding Risk (HBR); Long Lesions (LL) (e.g. ≥ 20 mm); Small Vessels (SV) (e.g. ≤ 2.75 mm); Multi-Vessel Disease (MVD); Male/Female; Old Patients (e.g. > 65 y)