Automated Abdominal Binder for Orthostatic Hypotension

Inclusion Criteria:

• Male and female subjects, age 40-80 years.
• Possible or probable Multiple Systems Atrophy and Pure Autonomic Failure as defined byConsensus Criteria.
• Neurogenic orthostatic hypotension defined as a ≥30-mm Hg decrease in SBP within 3minutes of standing associated with impaired autonomic reflexes determined byautonomic testing in the absence of other identifiable causes, and
• Moderate to severe orthostatic symptoms, defined as an Orthostatic Hypotension SymptomAssessment (OHSA) composite score ≥4 (self-rating Likert scale of 0 to 10, with 0reflecting absence of symptoms), within the first 10 minutes of the screeningorthostatic stress test, and that have an impact in quality of life, as defined by thepatient.
• Able and willing to provide informed consent.

Exclusion Criteria:

• Pregnancy.
• Systemic illnesses known to produce autonomic neuropathy, including but not limited todiabetes mellitus, amyloidosis, monoclonal gammopathies, and autoimmune neuropathies.
• History of known aortic aneurisms, thoracic, abdominal or pelvic surgery in the past 6months; symptomatic abdominal or inguinal hernias; severe gastroesophageal reflux;recent fractures or fissures of ribs, thoracic or lumbar spine; medical devicesimplanted on the abdominal wall or abdomen that would interfere with the binder; knownabdominal or pelvic tumors, cysts or enlarged spleen; intolerance to any increase inintraabdominal pressure.
• Pre-existing sustained supine hypertension ≥180/110.
• Bedridden patients or those who are unable to stand due to motor impairment or severeorthostatic hypotension.
• Clinically unstable coronary artery disease (recurrent angina despite medicaltherapy), or major cardiovascular or neurological event in the past 6 months (myocardial infarction, stroke or transient ischemic attacks).
• Concomitant use of anticoagulants