PTCA Catheter - India CDSCO Medical Device Registration

Product Information

The Maya Catheter is intended for dilatation of diseased segment(MAYA NC) in a coronary artery or a coronary bypass. The MAYA catheter is indicated 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 Maya PTCA catheter is therefore indicated to dilate the diseased segment(MAYA NC) in a coronary artery or a coronary bypass, to improve myocardial perfusion. It allows also for restoring coronary flow in patients with ST-segment elevation myocardial infarction. The patents should fulfil one or more of the following criteria: • Patients must be judged to be acceptable candidates for coronary bypass surgery. • Patients with single vessel atherosclerotic lesion(MAYA NC), subtotal and accessible to dilatation with guidewire and catheter. • Certain multi-vessel diseased patients may also be candidates for this procedure. • 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.