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.