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 definedby Consensus 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 HypotensionSymptom Assessment (OHSA) composite score ≥4 (self-rating Likert scale of 0 to 10,with 0 reflecting absence of symptoms), within the first 10 minutes of the screeningorthostatic stress test, and that have an impact in quality of life, as defined bythe patient.

• Able and willing to provide informed consent.

Exclusion Criteria:

• Pregnancy.

• Systemic illnesses known to produce autonomic neuropathy, including but not limitedto diabetes mellitus, amyloidosis, monoclonal gammopathies, and autoimmuneneuropathies.

• History of known aortic aneurisms, thoracic, abdominal or pelvic surgery in the past 6 months; 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;known abdominal or pelvic tumors, cysts or enlarged spleen; intolerance to anyincrease in intraabdominal pressure.

• Pre-existing sustained supine hypertension ≥180/110.

• Bedridden patients or those who are unable to stand due to motor impairment orsevere orthostatic 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