Drug Eluting Coronary Stent System - India CDSCO Medical Device Registration
Drug Eluting Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000728_6a11d97158630de4cf3efb410f3c818b_dbea1e2a7b9ac928f7ea8e08aa35cb25. This device is marketed under the brand name BioMatrix Alpha. The license holder is Curis Healthcare, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
BioMatrix Alpha
License Holder
Curis HealthcareDevice Class
Approving Authority
CDSCO
Product Information
The BioMatrix NeoFlex DES is indicated for improving coronary luminal diameter for the treatment of de novo lesions in native coronary arteries with a reference diameter ranging between 2.25 mm and 4.0 mm. Stents with length 33 mm and 36 mm are only available for artery diameters ranging between 2.5 mm and 3.5 mm. The BioMatrix NeoFlex DES with stent length up to 28 mm is also indicated for use in patients with: • ST elevated myocardial infarction (BioMatrix Alpha) • Acute Coronary Syndromes (BioMatrix Alpha) including ACS-STEMI, ACS-NSTEMI and Unstable Angina • Diabetes Mellitus
Drug Coated Coronary Stent System
Brand: BioMatrix Alpha
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Drug Eluting Coronary Stent System
Brand: BioMatrix Alpha
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Drug Eluting Coronary Stent System
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Drug Eluting Coronary Stent System
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Drug Coated Coronary Stent System
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Curis Healthcare
Drug Eluting Coronary Stent System
Brand: BioMatrix Alpha
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Drug Eluting Coronary Stent System
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Drug Eluting Coronary Stent System
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Cartier Healthcare LLP
Drug Eluting Coronary Stent System
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Cartier Healthcare LLP