Contraindications

Renew℠ Treatments are contraindicated for patients who have a history of the following:

  • Any surgical intervention within 6 weeks before Renew℠ Treatments.
  • Cardiac catheterization within 1-2 weeks before Renew℠ Treatments.
  • Uncontrolled arrhythmia or controlled arrhythmias that could interfere with cuff inflation and deflation triggering.
  • 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).
  • 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 Renew℠ Treatments.
  • Glucose greater than 200 mg/dL by glucometer for diabetic patients
  • Having a pacemaker
  • Prominent varicosities
  • Weight greater than 135 kg (297lbs)
  • Intellectual disabilities that prevent participation in treatment or answering questionnaires without assistants
  • Abnormal cognition as assessed by the Short Blessed Test (score greater than 4)
  • Decompensated congestive heart failure (noted on ECG during initial screening and physical examination- dyspnea, rales, edema, jugula pressure elevation, fatigue on exertion)

 

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

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