A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema

Inclusion Criteria:

• Males and females ≥ 18 years of age
• Capable and willing to sign the informed consent and deemed capable of following thestudy protocol
• Subjects must have a diagnosis of primary or secondary unilateral or bilateral lowerextremity edema or lower extremity phlebolymphedema from chronic venous insufficiency

Exclusion Criteria:

• Individuals with a history or presence of a systemic disorder or condition that couldplace the subject at increased risk from sequential compression therapy
• Inability or unwillingness to participate in all aspects of study protocol and/orinability to provide informed consent
• Subjects with exam results that would prevent safe and effective use of the studydevice (cellulitis, open-wounds, healing-wounds, etc.)
• Subjects must not have any diagnosed cognitive or physical impairment that wouldinterfere with use of the device
• Individuals who present with Ankle-brachial Index (ABI) screening score < 0.8 and > 1.30, indicating the possibility of Peripheral Arterial disease (PAD)
• Diagnosis of lipedema
• Diagnosis of active or recurrent cancer (< 3 months since completion of chemotherapy,radiation therapy or primary surgery for the cancer)
• Diagnosis of acute infection (in the last four weeks)
• Diagnosis of acute thrombophlebitis (in last 6 months)
• Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
• Diagnosis of pulmonary edema
• Diagnosis of congestive heart failure (uncontrolled/uncompensated)
• Diagnosis of chronic kidney disease with acute renal failure
• Diagnosis of epilepsy
• Subjects with poorly controlled asthma
• Any condition where increased venous and lymphatic return is undesirable
• Women who are pregnant, planning a pregnancy or nursing at study entry
• Participation in any clinical trial of an investigational substance or device duringthe past 30 days