Symptomatic neurogenic orthostatic hypotension in primary autonomic failure

nOH (neurogenic orthostatic hypotension) is a fall in blood pressure on standing caused by failed sympathetic vasoconstriction, and in this domain it rides on a neurodegenerative disease that also impairs dexterity, posture and cognition. Management is a ladder — remove aggravating drugs, non-pharmacologic measures (fluids, salt, counter-manoeuvres, compression of the legs and abdomen), then pressor drugs (midodrine, droxidopa) whose use is limited by supine hypertension. The domain is worth holding because two plausibly different candidates — a compression device and, say, a supine blood-pressure monitor or a fall-prevention product — would both read it.

Read the thinness before reading the content. First-pass dossier, one research session (2026-09-28). Section 5 is worked hardest and carries most of the citation weight. Every compression study below is short — study days, 1-week crossovers, a 4-week open-label extension — so there is no published home-use adherence figure for any abdominal compression product in nOH; the adherence rows in section 5 come from leg stockings in older OH (orthostatic hypotension) patients and from drug persistence in pharmacy claims, and are twins, not direct evidence. Sections 2 and 3 are thin. Section 6 is almost empty because the three CMS (Centers for Medicare & Medicaid Services) files the reimbursement connectors need are not cached in this environment. No /research-fleet report exists for this domain; /research-fleet plan neurogenic-orthostatic-hypotension is the cheaper next pass.

This file carries no confidence tags. Every line below is context with a source attached. To affect a score, a line must be copied into a candidate's ## Claims as unverified via engine/scripts/append_research_claims.py and pass the Verifier or the Corroborator. See README.md in this directory.

Citation convention: bracketed numbers [n] refer to the numbered ## Sources list at the end, which carries each entry's full resolvable identifier. Every PubMed item below was read at abstract depth via connectors literature-detail (unappraised: no methods, risk-of-bias or funding review) unless the row says full text was read.

1. Condition & epidemiology

as_of: 2026-09-28 · sources searched: connectors literature on PD (Parkinson disease) prevalence/incidence in North America, OH/nOH prevalence in PD, MSA (multiple system atrophy) incidence/prevalence, PAF (pure autonomic failure) natural history, supine hypertension prevalence; literature-detail on each PMID (PubMed identifier) cited · not searched: CMS Chronic Conditions Data Warehouse (no connector); any US figure for nOH prevalence across all causes; diabetic/amyloid autonomic neuropathy as nOH causes (out of this dossier's scope); DLB-specific nOH prevalence

Verbatim, for anything load-bearing:

"After standardization to the US population, the age-adjusted prevalence was 12.4 per 100,000 translating to 41,133 persons in the 2021 US population." — [5]

"Publication bias analysis suggested a small-sample effect; after adjustment using trimmed and inflated methods, the estimated prevalence decreased to 24.9%." — [3]

"There is no ICD-9-CM diagnosis code for nOH, so a combination of PD and OH diagnoses (with confounding conditions excluded) served as a proxy for an nOH diagnosis." — [12]

Underdiagnosis is itself a finding: only 36% of survey patients meeting criteria reported a formal OH/nOH diagnosis [11]; in 64 Dutch nursing-home PD residents, OH prevalence was 51.6%, only two symptomatic patients had it in their records, and none received midodrine [13]. The second is a non-US population.

Gaps: no US PAF prevalence (searched, not found). No US all-cause nOH prevalence (not searched as such). The PD × nOH arithmetic needed for a US nOH count has not been done here and should not be done by multiplying [1] by [3] without noting that [1] is a 2010 count with projections and [3] is a non-US-restricted pooled estimate. The MSA figure [5] is claims-based (≥1 claim) and the authors' own ≥2-claim figure is less than half of it. ICD-10-CM codes for this domain (I95.1, G90.3) were not checked: connectors icd needs data/icd10cm.csv, absent.

2. Care pathway & clinical setting

as_of: 2026-09-28 · sources searched: guideline/consensus abstracts [14]-[17], drug labels [39][40], the survey in [11] · not searched: referral patterns to autonomic centres; number of US autonomic testing labs; home-health or DME (durable medical equipment) supplier involvement; time from symptom onset to diagnosis

Verbatim:

"Physical measures include leg crossing, squatting, elastic abdominal binders and stockings, and careful exercise. Fludrocortisone is a valuable starter drug. Second line drugs include sympathomimetics, such as midodrine, ephedrine, or dihydroxyphenylserine." — [15] (EFNS, 2006; a European guideline)

Gaps: the US consensus statement [14] (American Autonomic Society + National Parkinson Foundation, 2017) was read at abstract depth only, and its abstract does not say what it recommends about compression — whether it names abdominal binders was not retrieved, and nothing here asserts it does. No site-of-service, staffing or supplier data.

3. User groups & incentives

as_of: 2026-09-28 · sources searched: the same survey, persistence and qualitative papers as section 5 · not searched: prescriber workforce counts; payer mix of the nOH population; caregiver time burden

Age anchor, not a payer-mix figure: NCT01971008 (a ClinicalTrials.gov registration number) posted median age 69 (IQR 66-75), 12 of 15 participants ≥65 [20]; NCT04620382 posted mean age 71 (SD 8), n=22 analysed [44]; the PAF cohort was 68 ± 12 at enrollment [8]; the ampreloxetine MSA subgroup was mean 63 (range 43-80) [60]; PD+nOH in MarketScan mean 77 [12]. These describe trial and claims cohorts, not the US nOH population, and do not establish what share is Medicare-insured.

Gaps: payer mix, prescriber counts, and who pays for a garment are all unestablished. Stakeholder preference is recorded nowhere in this file by design.

4. Standard of care & clinical evidence

as_of: 2026-09-28 · sources searched: connectors literature on consensus/guidelines, abdominal compression, compression systematic reviews, droxidopa and midodrine trials, ampreloxetine · not searched: fludrocortisone, pyridostigmine, atomoxetine evidence in detail; Cochrane reviews; the 2017 ACC/AHA/HRS syncope guideline (PMID 28280231) was surfaced by search but not read

Verbatim:

"Patient's education and non-pharmacological measures remain essential, with strong recommendation for use of abdominal binders." — [16]

"Only midodrine increased seated SBP (31±5 vs. 9±4 placebo and 7±5 binder, P=0.003); whereas orthostatic tolerance ... improved similarly with binder and midodrine" — [18]

"First, we only tested responses to the inflatable binder during ≤10 minutes of standing. ... Further studies are needed to assess the long-term efficacy, tolerability and practical use of the inflatable binder for the treatment of neurogenic OH." — [18] (full text, PMC4945429)

Gaps: every compression trial here is ≤4 weeks; none measures sustained home use. The registered Vanderbilt sham-controlled study of the automated binder (NCT03482297, 28 enrolled, COMPLETED) has no posted results as of 2026-09-28 [43], nor does the mechanism study NCT02429557 [45]. The Innsbruck double-blind binder study NCT04920552 is status UNKNOWN with an ESTIMATED enrollment of 30 and no results [46]. The Mayo adjustable-vs-elastic binder study NCT01223391 (13 enrolled) has no posted results [47].

5. Reference products — and why people stop using them

as_of: 2026-09-28

The load-bearing section. There is no product on the US market that does what an automated, posture-triggered abdominal compressor would do, so the reference set is the thing each such device would displace or sit alongside: passive abdominal binders, leg stockings, and the two pressor drugs — plus one regulatory analog and one investigational analog.

5.1 Elastic / hook-and-loop abdominal binders (passive)

• What it is / cleared indication: abdominal binders sit under 21 CFR (Title 21 of the Code of Federal Regulations) 890.3490 "Truncal orthosis", product code KTD "Orthosis, Abdominal", Class I, 510(k) (premarket notification)-exempt, whose identification is support or immobilisation of "fractures, strains, or sprains of the neck or trunk" — no haemodynamic indication [52]. One 510(k) record under the device name "ABDOMINAL BINDER" exists: K823663 (an FDA 510(k) clearance number), Warm & Form, 1982-12-30 [55]. No MAUDE (Manufacturer and User Facility Device Experience) report and no recall under KTD in the 10-year / 20-year windows queried [52].
• Price: unknown — not searched.
• Evidence behind it: sections 4 rows [16][19][21][22][23].
• Adoption: in a survey of 330 POTS + 28 nOH participants (mean age 37.9, 95% women — predominantly a POTS population), 13.4% reported abdominal compression as their most frequently used garment, versus 65.4% leg compression and 20.1% shapewear [29].
• Abandonment record — why people stop:

• Verbatim, for anything load-bearing:

"Most patients may require assistance applying them, making it difficult to selectively use abdominal compression only while standing. ... Thus, abdominal binders are effective treatments in laboratory settings, but their effectiveness is limited by difficulty of use and low compliance." — [18] (Okamoto et al., full text; the authors' own framing, not a measured adherence rate — no compliance figure is given)

5.2 Graduated compression stockings (leg)

• What it is: elastic leg garments; the midodrine label names "support stockings" among the standard non-pharmacologic care a patient should have tried first [40].
• Price: unknown — not searched.
• Evidence: knee/thigh-length inferior to abdominal-inclusive compression [24]; mean BP drop worsened with stockings but not binders over 1 week in PD [23].
• Abandonment record — why people stop:

• Verbatim:

"Thirty-three per cent wore ECS daily, whereas 43% never used them. Over half (51%) of the patients reported difficulty in application and 31% reported discomfort." — [28]

Population caveat: older adults with OH of mixed cause, UK — not nOH in primary autonomic failure specifically.

5.3 Midodrine (oral alpha-1 agonist)

• What it is / labeled indication: "indicated for the treatment of symptomatic orthostatic hypotension (OH)", restricted to "patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings)"; approval rests on a surrogate (1-minute standing SBP) [40]. Brand PROAMATINE was withdrawn from sale; FDA (US Food and Drug Administration) determined in 2019 that this was not for reasons of safety or effectiveness, allowing generic ANDAs [41]. FDA opened a public docket in 2011 on "trials needed to verify and describe the clinical benefit of midodrine" [42].
• Price: unknown — not searched.
• Evidence: label: "clinical benefits of midodrine hydrochloride, principally improved ability to carry out activities of daily living, have not been verified" [40].
• Adoption: 117,243 midodrine patients met inclusion in one US pharmacy-claims dataset, mid-2014 to 2018 [30] — a count of patients with ≥16 quarters of claims and a ≥30-day prescription, not an installed base.
• Abandonment record — why people stop:

5.4 Droxidopa (NORTHERA, norepinephrine prodrug)

• What it is / labeled indication: orthostatic dizziness, lightheadedness or "feeling that you are about to black out" in adults with symptomatic nOH caused by primary autonomic failure (PD, MSA, PAF), DBH deficiency and non-diabetic autonomic neuropathy; **"Effectiveness beyond 2 weeks of treatment has not been established"**; boxed warning: supine hypertension [39].
• Price: unknown — not searched.
• Evidence: pivotal randomised withdrawal, 7-day double-blind [34]; open-label durability to 12 months [35][36][37].
• Abandonment record — why people stop:

• Verbatim:

"Median (95% CI) treatment persistence was significantly longer in the droxidopa cohort versus the midodrine cohort (303 [274-325] vs 172 [169-176] days; P < 0.001)." — [30]

Reading caveat for [30]: the midodrine cohort includes OH of any cause, the droxidopa cohort is nOH by label; the comparison is confounded by indication, and the abstract does not disclose funding.

5.5 Regulatory analog — pneumatic anti-shock trousers (product code LHX)

• What it is: openFDA classification lists **LHX "Trousers, Anti-Shock", Class II (FDA device class II), under 21 CFR 870.5800** — the same regulation as JOW "Sleeve, Limb, Compressible" — and PPS "Sleeve, Head And Neck, Compressible" is also listed under 870.5800 [51]. So the regulation whose text says "limb" already houses at least two non-limb-sleeve product codes. Two LHX 510(k)s since 1986: K874774 "TROUSERS, PNEUMATIC, ANTI-SHOCK THREE BLADDERS" (Vinyl Technology, 1988-02-08) and K953763 "GLADIATOR ANTISHOCK PANTS" (Jobst Institute, 1995-11-28) [53]; a third, K904267 Zoex Antishock Trousers (1991-03-18), surfaced by device-name search [53].
• What was NOT established: whether any LHX device compresses the abdomen (the name "three bladders" suggests but does not say so); the IFU (instructions for use) text of any LHX clearance — the K953763 summary PDF returned HTTP 404 and pre-2000 summaries are generally not posted [53]. The PPS clearance summary K153311 returned HTTP 401 — not retrieved, and a 401 is not an absence [54].
• Abandonment record: LHX has only two clearances in 40 years and none after 1995 [53]. That is a count, not a reason. MAUDE under LHX is miscoded noise — the 50 records sampled of 78 are orthopaedic and spinal instruments (Smith+Nephew, Arthrex, NuVasive), not garments — so it says nothing about anti-shock trousers [51]. One LHX recall, Z-0792-2010, is a Stryker spine instrument, likewise miscoded [51].

5.6 Adjacent pneumatic compression hardware (JOW) — failure modes of the control loop

• JOW recalls, 10-year window, 16 records [57]: Z-1917-2025 / Z-1918-2025 / Z-1919-2025, Cardinal Health Kendall SCD sleeves: "Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy", FDA root cause "Software change control". Z-2324-2021 / Z-2325-2021: DVT devices "marketed without FDA clearance". Z-1343-2019 to Z-1348-2019: MediPress design change lacking a 510(k). Remaining records are sterility and labelling. Recall records have no denominator.

5.7 Investigational analog — Vanderbilt automated inflatable abdominal binder

• What it is: servo-controlled bladder at the umbilicus held at ~40 mmHg; first a cart-mounted commercial inflator, then a portable pump and controller [18].
• How it was actually operated in the published study: "Both inflators were **manually activated** to provide a compression level of ~40 mmHg <2 minutes before the post-intervention orthostatic tolerance test. ... The time taken to inflate or deflate the bladder with either pump was <30 seconds." [18] The paper describes activation "manually or with an automated posture detector" as a potential advantage [18]; the tested protocol did not use a posture detector.
• Tolerability: "One subject reported mild abdominal discomfort with a compression level of 40 mmHg, but deflation to a lower compression level (20 mmHg) improved the discomfort" — n=19 [18]. NCT04620382 (40 mmHg compression vs midodrine, single study day each): 31 enrolled, 22 completed, 0 serious or other AEs in either arm among 22 at risk; reasons for the 9 non-completions not posted [44].
• Adoption / abandonment: none — never marketed. Related patent publication US2015313608 "Compression device, system, and method for decreasing abdominal venous pooling", filed 2013-11-04, naive expiry 2033-11-04; grant status not determined [65].

5.8 Other devices in development (not marketed)

• Isotech Ltd ISO (International Organization for Standardization)-101, NCT06039410: single-group "signal of effectiveness" study in OH, enrollment 30 ESTIMATED, status UNKNOWN, no results; the registry summary does not say what the device does, and nothing here infers it [48].
• A motor-driven "active abdominal compression binder" that applies compression "upon the detection of standing" was tested in 20 healthy volunteers aged 18-50, reaching ~11 mmHg (SD ~1) vs ~8 mmHg (SD ~3) for a passive binder [49].
• An inflatable binder bench-tested on a manikin: authors suggest not exceeding 25 mmHg for safe external abdominal pressure, against a "general recommendation" of 20-40 mmHg [50]. Manikin data, not human.

Gaps: no home-use adherence or discontinuation figure for any abdominal compression product in nOH — searched, not found. No price for any garment — not searched. No MAUDE sweep of JOW (adjacent, but it has no denominator). Drug label recalls/shortages not searched (no drug connector). Stated reasons for drug discontinuation are absent from both claims studies.

6. Reimbursement landscape

as_of: 2026-09-28

Verbatim:

"Pneumatic compression devices consist of an inflatable garment for the arm or leg and an electrical pneumatic pump that fills the garment with compressed air." — [59]

Gaps: three of the four reimbursement connectors are blocked on missing CMS files (hcpcs_level_ii.csv, hcpcs_payment_rates.csv, medicare_coverage_policies.csv), and the DMEPOS volume release is uncached (connectors procedures E0650 → "Nothing was looked up in either direction", docs/backlog.md 1.13). These are published federal files and engine/scripts/fetch_data_file.py exists to fetch them with provenance; they were not fetched in this pass. Nothing in this section may be read as "no code" or "no payment".

7. Technology trajectory

as_of: 2026-09-28

Posture-classification caveat (relevant to any posture-triggered device): postural deformity is common in MSA — camptocormia 15.6%, Pisa syndrome 4.2%, antecollis 3.3% of 732 consecutive Chinese MSA patients [64]. No study was found reporting a false-"upright" classification rate for a torso sensor in PD or MSA patients with camptocormia (searched, 1 relevant hit [63], no figures).

Gaps: clearance counts per year for compression product codes not compiled (a counted series cannot carry a tag anywhere in this repo, backlog 1.10). No De Novo (De Novo classification request) grant matches "abdominal compression", "abdominal binder", "orthostatic", "splanchnic" or "compression garment" by device name in the cached FDA De Novo listing (494 records, retrieved 2026-09-24) [56] — a device-name search, not an indication search, so a differently-named grant would not surface.

8. Market players & dynamics

as_of: 2026-09-28

Gaps: no company-financing, FDA registration-and-listing, or commercial-garment vendor search was run (no connector). Assignee search against pneumatic-compression incumbents not run.

9. Open questions — and what would settle them

10. Provenance & staleness

Connector anomaly recorded, not resolved: connectors policy 2019-23014 and connectors policy 2011-355 each reported the document "retrieved in full (1,717 characters)" and returned unconfirmed for phrases that the Federal Register API abstract for the same document contains. Two different documents at an identical length suggests the connector read something other than the document body (compare the 401-page hazard in docs/research-lane-spec.md §7). The abstracts quoted in section 5.3 were read from the Federal Register API directly.

What this dossier has never looked at: garment or drug prices of any kind; Part D coverage of midodrine and droxidopa; any DME MAC (durable medical equipment Medicare administrative contractor) LCD; HCPCS (Healthcare Common Procedure Coding System) codes, fee schedules and DMEPOS volumes (missing caches); MAUDE for JOW; ex-US anything; FDA guidance documents on compression devices (fda.gov gates automated requests); commercial abdominal-binder vendors and their sales; the full text of the US consensus statement; any posted result from NCT03482297; patient-reported reasons for stopping droxidopa or midodrine (not found in the claims studies); prevalence of nOH outside PD/MSA/PAF. Absence of scanning is not absence of change.

Sources

1. PMID 30003140 — Marras C et al., "Prevalence of Parkinson's disease across North America", 2018
2. PMID 36522332 — "Incidence of Parkinson disease in North America", 2022
3. PMID 41767005 — "Prevalence and incidence of orthostatic hypotension in patients with Parkinson's disease: an updated systematic review and meta-analysis", 2026
4. PMID 38692034 — "Longitudinal prevalence of neurogenic orthostatic hypotension in the idiopathic Parkinson Progression Marker Initiative (PPMI) cohort", 2024
5. PMID 37951144 — "Estimating the prevalence and incidence of multiple system atrophy in the USA: Insights from a national claims database", 2023
6. PMID 9371909 — "Incidence of progressive supranuclear palsy and multiple system atrophy in Olmsted County, Minnesota, 1976 to 1990", 1997
7. PMID 38453600 — "Prevalence of multiple system atrophy: A literature review", 2024
8. PMID 28093795 — "Natural history of pure autonomic failure: A United States prospective cohort", Ann Neurol 2017;81:287-297
9. PMID 42081229 — "Phenoconversion in Pure Autonomic Failure: A Systematic Review and Meta-Analysis", 2026
10. PMID 40406920 — "Prevalence of Supine Hypertension in Alpha-Synucleinopathies: A Systematic Review and Meta-Analysis", 2025
11. PMID 30144800 — "Characterization of the symptoms of neurogenic orthostatic hypotension and their impact from a survey of patients and caregivers", 2018
12. PMID 28125950 — "Fall-related healthcare use and costs in neurogenic orthostatic hypotension with Parkinson's disease", 2017
13. PMID 27662327 — "Prevalence and Prescribed Treatments of Orthostatic Hypotension in Institutionalized Patients with Parkinson's Disease", 2016
14. PMID 28050656 — "The recommendations of a consensus panel for the screening, diagnosis, and treatment of neurogenic orthostatic hypotension and associated supine hypertension", 2017 (abstract only)
15. PMID 16930356 — "EFNS guidelines on the diagnosis and management of orthostatic hypotension", 2006
16. PMID 29058089 — "Evidence-based treatment of neurogenic orthostatic hypotension and related symptoms", 2017
17. PMID 38205630 — "Orthostatic Hypotension in Adults With Hypertension: A Scientific Statement From the American Heart Association", 2024
18. PMID 27271310 / PMC4945429 — Okamoto LE et al., "Efficacy of Servo-Controlled Splanchnic Venous Compression in the Treatment of Orthostatic Hypotension: A Randomized Comparison With Midodrine", Hypertension 2016 (full text read)
19. PMID 30363559 — "Elastic Abdominal Binders Attenuate Orthostatic Hypotension in Parkinson's Disease", 2016
20. NCT01971008 — ClinicalTrials.gov posted results (participant flow, baseline, adverse events), Medical University Innsbruck, record updated 2023-03-10; read via ClinicalTrials.gov API v2 2026-09-28
21. PMID 15241645 — "Use of lower abdominal compression to combat orthostatic hypotension in patients with autonomic dysfunction", 2004
22. PMID 25448247 — "Effects of patient-controlled abdominal compression on standing systolic blood pressure in adults with orthostatic hypotension", 2015
23. PMID 36278359 — "Effect of Lower Limb vs. Abdominal Compression on Mobility in Orthostatic Hypotension: A Single-Blinded, Randomized, Controlled, Cross-Over Pilot Study in Parkinson's Disease", 2022
24. PMID 24659590 — "Compression therapy in patients with orthostatic hypotension: a systematic review", 2014
25. PMID 31868889 — "Combination non-pharmacologic intervention for orthostatic hypotension in older people: a phase 2 study", 2020
26. PMID 30558552 — "Acceptability of non-drug therapies in older people with orthostatic hypotension: a qualitative study", 2018
27. PMID 35286620 — "Strategies to improve uptake and adherence of non-pharmacologic interventions for orthostatic hypotension in older people: a qualitative study", 2022 (read; not cited in a table — records that uptake/adherence of non-drug therapy is described as "challenging")
28. PMID 25344314 — "Therapeutic use of compression stockings for orthostatic hypotension: an assessment of patient and physician perspectives and practices", 2015
29. PMID 39685762 — "Current Landscape of Compression Products for Treatment of Postural Orthostatic Tachycardia Syndrome and Neurogenic Orthostatic Hypotension", 2024
30. PMID 32200263 — "Real-world droxidopa or midodrine treatment persistence in patients with neurogenic orthostatic hypotension or orthostatic hypotension", 2020
31. PMID 24008021 — "Early discontinuation of treatment in patients with orthostatic hypotension", 2013
32. PMID 34421309 — "Droxidopa Persistence in Neurogenic Orthostatic Hypotension May Be Affected by Titration Approach", 2021
33. PMID 30949555 — "Six-Month Use of Droxidopa for Neurogenic Orthostatic Hypotension", 2019
34. PMID 24944260 — "Droxidopa for neurogenic orthostatic hypotension: a randomized, placebo-controlled, phase 3 trial", 2014
35. PMID 27614923 — "Long-term safety of droxidopa in patients with symptomatic neurogenic orthostatic hypotension", 2016
36. PMID 27636856 — "Safety and Durability of Effect with Long-Term, Open-Label Droxidopa Treatment ... (NOH303)", 2016
37. PMID 35107750 — "Durability of the Clinical Benefit of Droxidopa for Neurogenic Orthostatic Hypotension During 12 Weeks of Open-Label Treatment", 2022 (NCT02586623)
38. PMID 28159196 — "Cardiovascular Safety of Droxidopa in Patients With Symptomatic Neurogenic Orthostatic Hypotension", 2017
39. DailyMed SPL setid 2179f02c-48d7-48eb-8007-5ae43d8d16bc — NORTHERA (droxidopa) capsule, Lundbeck, published 2025-12-17; read via DailyMed services v2 API 2026-09-28
40. DailyMed SPL setid aec0d2de-ce83-b7c2-5d10-740607d50521 — Midodrine hydrochloride tablet, Apotex, published 2026-09-15; read via DailyMed services v2 API 2026-09-28
41. Federal Register 2019-23014 (84 FR 56459) — "Determination That PROAMATINE (Midodrine Hydrochloride) Tablets ... Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness", 2019-10-22 (abstract via federalregister.gov API)
42. Federal Register 2011-355 (76 FR 1620) — "Trials to Verify and Describe Clinical Benefit of Midodrine Hydrochloride; Establishment of Public Docket", 2011-01-11 (abstract via federalregister.gov API)
43. NCT03482297 — "Automated Abdominal Binder for Orthostatic Hypotension", Vanderbilt, hasResults=false, record updated 2026-05-05
44. NCT04620382 — "Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients", Vanderbilt, posted results read via ClinicalTrials.gov API v2 2026-09-28
45. NCT02429557 — "Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure", Vanderbilt, hasResults=false
46. NCT04920552 — "Abdominal Binders to Treat Orthostatic Hypotension in Parkinsonian Syndromes", Innsbruck, status UNKNOWN
47. NCT01223391 — "Abdominal Compression in Orthostatic Hypotension", Mayo Clinic, hasResults=false
48. NCT06039410 — "A Novel Device for the Treatment of Postural Hypotension - a Signal of Effectiveness Study", Isotech Ltd, status UNKNOWN
49. PMID 41483109 — "A Portable, Active Abdominal Compression Binder for Orthostatic Intolerance: Design and Evaluation in Healthy Subjects", 2026
50. PMID 39311288 — "A Safety-Centric Study on the Use of Inflatable Abdominal Binders for Managing Orthostatic Hypotension", 2024
51. openFDA device/classification product codes JOW, LHX, PPS (regulation 870.5800); openFDA MAUDE product_code LHX (2016-09-30 to 2026-09-28, 78 matches, 50 sampled); recall Z-0792-2010
52. 21 CFR 890.3490 (eCFR, issue 2026-09-22); openFDA device/classification product code KTD; MAUDE KTD 10-year window (none); recalls KTD 20-year window (none)
53. 510(k) K874774, K953763, K904267 (openFDA device/510k); clearance-summary K953763 → HTTP 404
54. 510(k) K153311 (Flexitouch, product code PPS, 2016-09-14); clearance-summary K153311 → HTTP 401, not retrieved
55. 510(k) K823663 — "ABDOMINAL BINDER", Warm & Form, 1982-12-30 (openFDA device/510k)
56. FDA De Novo listing cache data/fda_denovo.csv — 494 records, retrieved 2026-09-24 from accessdata.fda.gov denovo.cfm, sha256 c95e264f…7cfd (data/provenance.json); device-name searches run 2026-09-28
57. FDA recalls, product code JOW, 2016-09-30 to 2026-09-28: Z-1917-2025, Z-1918-2025, Z-1919-2025, Z-1612-2023, Z-2324-2021, Z-2325-2021, Z-1343-2019 to Z-1348-2019, Z-1041-2019, Z-1985-2019, Z-0272-2018
58. (reserved — unused)
59. NCD 280.6 — CMS Pub. 100-3 Medicare NCD Manual, ch. 1 pt. 4 (Rev. 13808, issued 05-29-26), via connectors ncd 280.6 2026-09-28
60. PMID 42475649 — "Mechanism-Based Therapy With Ampreloxetine for Neurogenic Orthostatic Hypotension in Multiple System Atrophy: A Randomized Withdrawal Trial", 2026
61. NCT05696717 — ampreloxetine phase 3 in MSA, Theravance, ACTIVE_NOT_RECRUITING, 102 ESTIMATED
62. NCT04095793, NCT03829657 — ampreloxetine phase 3s, TERMINATED ("Stopped early due to company decision")
63. PMID 18075046 — "Ambulatory monitoring of physical activities in patients with Parkinson's disease", 2007
64. PMID 30987897 — "Prevalence of and factors associated with postural deformities in Chinese patients with multiple system atrophy", 2019
65. EPO (European Patent Office) OPS publication epodoc US2015313608 — "Compression device, system, and method for decreasing abdominal venous pooling", filed 2013-11-04 (via connectors patent 2026-09-28)