PTCA Catheter - India CDSCO Medical Device Registration
PTCA Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000564_a7d36f5934a191ef9b9439fd936fe51d_2cd16a11e3f36908e341af1c3e8678e2. This device is marketed under the brand name CYGNUS II. The license holder is Envision Scientific Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
CYGNUS II
License Holder
Envision Scientific Pvt. Ltd.Device Class
Approving Authority
CDSCO
Product Information
It 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. The Vega PTCA catheter is therefore indicated to dilate the diseased segment(CYGNUS II) in a coronary artery or a coronary bypass, to improve myocardial perfusion. The patients should fulfill one or more of the following criteria: 1. Patients must be judged to be acceptable candidates for coronary bypass surgery. 2. Patients with single vessel atherosclerotic lesion(CYGNUS II), non-calcified, subtotal and accessible to dilatation with guidewire and catheter. 3. Certain multi-vessel diseased patients may also be candidates for this procedure. 4. Certain patients, who have undergone previous coronary bypass surgery with recurrence of symptoms and progression of the disease in the coronary artery, or stenosis and closure of the grafts, may also be candidates.
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