The Renew® ECP , NCP-5 is contraindicated in the treatments of patients who have a history of the following:

  • Any surgical intervention within 6 weeks before ECP treatment.

  • Cardiac catheterization within 1-2 weeks before ECP treatment.

  • Uncontrolled arrhythmia or controlled arrhythmias that could interfere with ECP inflation and deflation triggering.

  • Dual chamber pacemakers with atrial pacing may interfere with ECP inflation timing sequence. This should be addressed prior to treatment.

  • Aortic insufficiency (regurgitation can prevent diastolic augmentation).

  • Severe pulmonary disease.

  • Limiting peripheral vascular disease involving the ileofemoral arteries.

  • Deep-vein thrombophlebitis (risk of thromboembolus).

  • Severe hypertension (≥ 180 mm Hg systolic or ≥ 110 diastolic).

  • Limiting peripheral vascular disease involving the ileofemoral arteries.

  • Deep-vein thrombophlebitis (risk of thromboembolus).

  • Bleeding disorders.

  • Patients undergoing major anti-coagulation therapy (such as Heparin therapy or Coumadin® therapy) with PT > 1.5.

  • Heart rates less than 35 or more than 125 beats per minute. (Patients with these heart rates should be evaluated and treated prior to ECP treatments).

  • Presence of abdominal aortic aneurysm.

  • Presence of local infection, vasculitis of the extremities.

  • Pregnant women and women of childbearing age who do not have a negative pregnancy test.

  • Presence of a burn, open wound, or bone fracture on any limb subject to ECP treatment.

COUMADIN® is a registered trademark of Bristol-Myers Squibb Pharma Company.