PTCA Catheter - India CDSCO Medical Device Registration

Product Information

The indications and contra-indications are defined for sterile catheters. It is advisable to confirm them for the final device. It is intended to dilate a stenotic portion of a native coronary artery or a bypass graft stenosis for the purpose of improving myocardial perfusion and the for post-dilatation of stents (MAYA NC). The patients should fulfill 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. • Patients who are undergoing a stent implantation with a stent post-dilatation