Sirolimus Coated Balloon Catheter - India CDSCO Medical Device Registration
Sirolimus Coated Balloon Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID G/28/1396_5410914391313a4558766d6188e5cd6f_b8be908a0963bc722c41da9c0cf7193e. This device is marketed under the brand name Devoir, Vanquisher. The license holder is Envision Scientific 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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Brand Name
Devoir, Vanquisher
License Holder
Envision Scientific Pvt. Ltd.Device Class
Approving Authority
Central Drug Standards Control Organization, Ahmedabad
Product Information
Sirolimus Coated Balloon Catheter is intended for use in the treatment of patients with clinical symptoms of myocardial ischemia related to the pathological condition of one or more coronary arteries. Sirolimus Coated Balloon Catheter is therefore indicated to dilate the diseased segment(Devoir, Vanquisher) and deliver drug in a coronary artery or a graft, to improve myocardial perfusion with balloon lengths ranging from 10.00 to 40.00 mm and diameters ranging from 1.50 mm to 4.00 mm to treat lesion length from 8.00 mm to 38.00 mm. The device is intended for use in following conditions: Patients with In‐stent restenosis of previous stent implantation. Patients with disease in small vessels where Drug eluting stent implantation is either not feasible or involving higher risk of restenosis. Patients with bifurcation lesions, where side branch stent treatment increases risks of dissection, restenosis and a balloon catheter treatment is more advised
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