Sirolimus Coated Balloon Catheter(Magic Touch, Devoir, Vanquisher & Magic Touch- SCB) - India CDSCO Medical Device Registration

Sirolimus Coated Balloon Catheter(Magic Touch, Devoir, Vanquisher & Magic Touch- SCB) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000235_c7d9eae94db330718f65a95c8f7be8a3_4dc5a9200b6c5d162c2d961c4b326fd1. This device is marketed under the brand name Magic Touch - AVF. 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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CDSCO Registered

Class Class D

Sirolimus Coated Balloon Catheter(Magic Touch, Devoir, Vanquisher & Magic Touch- SCB)

UID: MFG/MD/2020/000235_c7d9eae94db330718f65a95c8f7be8a3_4dc5a9200b6c5d162c2d961c4b326fd1

Brand Name

Magic Touch - AVF

License Holder

Envision Scientific Pvt. Ltd.

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Sirolimus Coated Balloon Catheter is indicated for treatment of Coronary Artery Disease by performing Percutaneous Transluminal Coronary Angioplasty, after appropriate lesion preparation. Sirolimus Coated Balloon Catheter is therefore indicated to dilate the diseased segment(Magic Touch - AVF) in coronary artery by delivering drug in coronary artery or graft with lesion lengths of 6.00 mm to 36.00 mm and reference vessel diameter from 1.50 mm to 4.00 mm. The device is intended for use in following conditions: • Patients with de-novo lesion; • Patients with In‐stent restenosis of previous stent implantation; • Patients with disease in small vessels where 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 recommended.