Generally, lesions most accessible to DCA are those in the proximal or mid-portion of coronary arteries. Patients with calcified aorto-ostial lesions. Patients who are not suitable candidates for CABG surgery. Patients with totally obstructed coronary arteries where a guidewire cannot be advanced through the occlusion. Patients with permanent intracoronary stents within the target lesion vessel.
Single patient is defined as one complete procedure on one patient.
Appropriate anticoagulant and coronary vasodilator therapy must be used during this procedure. Never use air or any gaseous medium to inflate the balloon when it is inside the patient. Use of higher concentrations of contrast medium will result in prolonged balloon inflation and deflation times, and prolonged interruption of blood flow. Use of this system with inadequate fluoroscopic guidance could result in vessel injury. Exposure to extreme temperatures may damage product.