Exposure to extreme temperatures may damage product. 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 coronary artery bypass graft surgery. Patients with totally obstructed coronary arteries where a guidewire cannot be advanced through the occlusion.
Single patient is defined as one complete procedure on one patient.
Failure to do so may result in balloon rupture due to overpressurization, and, if so, will consequently injure the vessel. A cardiac surgery team should be on alert while atherectomy is being performed. 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.