Everolimus Eluting Coronary Stent System
- UID
- MFG/MD/2022/000667_c87d460d00d3564b32bb8aea8cee3662_f76f4fcab5926fe648271dce7bda4755
- Device class
- Class D
- Brand name
- XTRACK+, XTRACK PRO
- License holder
- Veritas Bioventions Pvt. Ltd.
- Approving authority
- Central Drug Standards Control Organization, Ahmedabad
- Product information
- The Coronary Stent is indicated for selective implantation and for treatment of acute or threatened closure following intervention in the coronary vasculature, including saphenous vein grafts & is intended to improve coronary luminal diameter. The issues of repeated restenosis are always big problem in metallic stent and to overcome this issue Drug eluting Stents (XTRACK+, XTRACK PRO) are use for angioplasty. The Everolimus eluting coronary stent system (XTRACK+, XTRACK PRO)is indicated for use in patients with symptomatic ischemic heart disease due to discrete de novo coronary artery lesions with a reference vessel. Diameter ranging from 2.00 mm to 4.50 mm and is intended to improve coronary luminal diameter
Everolimus Eluting Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000667_c87d460d00d3564b32bb8aea8cee3662_f76f4fcab5926fe648271dce7bda4755. This device is marketed under the brand name XTRACK+, XTRACK PRO. The license holder is Veritas Bioventions Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
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