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At-home diuretic pump cuts hospital stays for heart failure patients in trial

At-home diuretic pump cuts hospital stays for heart failure patients in trial

New Capabilities

Subcutaneous furosemide delivered via wearable pump added 4 days alive and out of hospital at 30 days, with safety on par with inpatient care

October 14th, 2026: Full trial results published in JACC

Overview

Updated Oct 18

A randomized trial published October 14 in the Journal of the American College of Cardiology found that heart failure patients sent home with a wearable diuretic pump gained four days alive and out of hospital over the next month, versus usual inpatient care. Real-world results presented three days earlier at a Heart Failure Society of America meeting showed 86% of at-risk patients treated at home cleared their congestion without being admitted.

Medicare's first billing code for the pump took effect October 1, an early step toward routine payment. The trial's at-home group had more heart-failure readmissions (14% vs 6% at 60 days), a gap payers and guideline writers will weigh against the beds freed up.

Why it matters

If this pathway becomes standard care, heart failure congestion treatment moves out of hospital beds, cutting per-episode costs and freeing capacity.

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Key Indicators

4.0 days
Extra days alive and out of hospital at 30 days
Primary endpoint of SUBCUT HF II, favoring the at-home early-discharge group (P < 0.001).
5.5 days
Cut from average index hospital stay
Mean index hospitalization was 5.5 days shorter for the early-discharge group (95% CI 3.6-7.4; P<0.001).
86%
At-risk patients decongested at home without admission
18 of 21 patients in the University of Florida's Gator SCALES-WHF study avoided hospitalization.
172
Patients enrolled across 20 UK NHS hospitals
92 assigned to early discharge with home pumps, 80 to usual inpatient care.
25%
Serious adverse events in the at-home group
Comparable to 23% in usual care; no serious device-related events occurred.

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People Involved

Pieter Muntendam
Pieter Muntendam
Founder, President and CEO of SQ Innovation
Pursuing European market authorization after CE marking; Medicare's billing code for Lasix ONYU took effect October 1, 2026
RC
Ross T. Campbell
Principal Investigator, Glasgow Cardiovascular Research Centre
Co-led SUBCUT HF II across 20 NHS hospitals
MP
Mark C. Petrie
Principal Investigator, Glasgow Cardiovascular Research Centre
Co-led SUBCUT HF II; emphasizing patient selection for home discharge

Organizations Involved

SQ Innovation
SQ Innovation
Medical device and pharmaceutical company
Holding US approval and CE marking; Medicare billing code J1946 effective October 1, 2026

Developed Lasix ONYU, a wearable pump delivering subcutaneous furosemide for heart failure edema.
UG
University of Glasgow
University and research institution
Trial co-sponsor through the Glasgow Cardiovascular Research Centre

Co-sponsored SUBCUT HF II and hosted its principal investigators.
GG
NHS Greater Glasgow and Clyde Health Board
National Health Service health board
Trial co-sponsor

Co-sponsored SUBCUT HF II with the University of Glasgow.
MannKind Corporation
MannKind Corporation
Biopharmaceutical company
FDA approved Furoscix ReadyFlow in July 2026

MannKind's Furoscix ReadyFlow is a competing subcutaneous furosemide autoinjector.

Timeline

2024 October 2026

8 events Latest: October 14th, 2026 · 4 weeks ago
Tap a bar to jump to that date

  1. Full trial results published in JACC

    Latest Publication

    Complete SUBCUT HF II results published, showing four more days alive and out of hospital at 30 days.

  2. Real-world data: 86% of at-risk patients treated at home avoided admission

    Study Presentation

    Interim results of the Gator SCALES-WHF study at the University of Florida, presented at HFSA 2026 in Phoenix, showed 18 of 21 heart failure patients at imminent risk of admission were decongested at home without a hospital stay.

  3. Medicare billing code takes effect for Lasix ONYU

    Regulatory

    CMS's new HCPCS Level II code J1946 for the subcutaneous furosemide pump went into effect, letting providers bill it under the medical benefit when furnished incident to a physician's service.

  4. FDA approves competing Furoscix ReadyFlow autoinjector

    Regulatory Approval

    MannKind's Furoscix ReadyFlow, which delivers the same 80 mg/mL furosemide dose in under 10 seconds, was approved for fluid overload in heart failure and chronic kidney disease, competing with Lasix ONYU in the at-home market.

  5. SUBCUT HF II results presented in Barcelona

    Study Presentation

    Topline results shown in the Hottest Trials session at the Heart Failure Association congress of the European Society of Cardiology.

  6. Lasix ONYU receives CE marking; EMA accepts centralized review

    Regulatory Approval

    SQ Innovation's device gained CE marking under the EU Medical Device Regulation, and the European Medicines Agency accepted the product for centralized review on the basis of technical innovation.

  7. FDA approves Lasix ONYU

    Regulatory Approval

    US Food and Drug Administration clears the wearable pump delivering 80 mg subcutaneous furosemide over five hours.

  8. Pilot trial supports subcutaneous furosemide

    Study

    AT HOME-HF pilot finds subcutaneous furosemide safely augments weight loss in congested heart failure patients.

Scenarios

1

At-home subcutaneous diuresis becomes standard heart failure care

Uncertain Resolves by End of 2028

Discussed by: Trial investigators at the University of Glasgow and SQ Innovation leadership

If payers and guideline bodies accept the SUBCUT HF II evidence, hospitals adopt early supported discharge with wearable furosemide pumps as a routine pathway for stable congested heart failure patients. The UK's National Institute for Health and Care Excellence (NICE) and the US Centers for Medicare and Medicaid Services (CMS) would need to approve reimbursement, and the higher heart failure readmission rate would have to be accepted against the savings in beds and costs.

2

Readmission imbalance prompts regulatory caution

Possible Resolves by End of 2027

Discussed by: The published trial results and regulators reviewing them

At 60 days, early-discharge patients had more heart failure readmissions: 13 (14%) versus 5 (6%), an odds ratio near 2.45 that did not reach statistical significance. Regulators could still flag the imbalance and request a larger confirmatory trial or restrict at-home use to low-risk patients. That would slow adoption without stopping it.

3

Lasix ONYU expands to new markets before US reimbursement settles

Likely Resolves by Q2 2028

Discussed by: SQ Innovation

With FDA approval already in hand and positive trial data now published, the company could file for European or UK marketing authorization while US payer decisions and guideline updates take shape. Success depends on regulators outside the US weighing the readmission signal differently than their American counterparts.

4

Two subcutaneous furosemide products split the at-home market

Likely Resolves by End of 2027

Discussed by: MannKind and SQ Innovation

MannKind's Furoscix ReadyFlow, FDA-approved in July 2026, delivers an 80 mg dose in under 10 seconds from an autoinjector. Lasix ONYU infuses the same dose over five hours from a wearable pump. Both target outpatient decongestion, and coverage decisions by CMS and NICE will likely decide whether one or both become routine options.

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

1970s

Home peritoneal dialysis (1970s)

Chronic kidney disease patients who once required thrice-weekly dialysis in a clinic learned to run peritoneal dialysis at home with portable equipment, exchanging fluid through a catheter in their abdomen. The approach matched survival outcomes of in-center hemodialysis.

Then

Home dialysis became a standard option, cutting clinic capacity needs and letting patients dialyze overnight.

Now

It established the template for moving a procedure-intensive chronic therapy out of the hospital.

Why this matters now

The furosemide pump applies the same logic to a common acute heart failure treatment that most patients still receive in a hospital bed.

November 2020

CMS Acute Hospital Care at Home (2020)

The US Centers for Medicare and Medicaid Services (CMS) waived rules so hospitals could treat selected acute patients at home, including those with heart failure, instead of admitting them. The pandemic prompted the waiver.

Then

Hundreds of hospitals used the waiver, and study data showed comparable outcomes with fewer complications.

Now

Hospital-at-home shifted from a niche experiment to a reimbursed care model, though it remains limited to stable, carefully selected patients.

Why this matters now

SUBCUT HF II tests the same idea with a specific device rather than a general waiver, and it quantifies the bed-day savings a hospital-at-home program produces.

1978-2000s

Insulin pumps for diabetes (1978-2000s)

Insulin delivery moved from hospital-managed injections to patient-operated wearable pumps that administer precise doses around the clock. Early devices were bulky and prone to failure; successive generations became smaller and safer.

Then

Continuous subcutaneous insulin infusion became standard for type 1 diabetes, letting patients manage a demanding therapy outside clinics.

Now

It proved patients can safely self-manage complex drug delivery when the device is designed for it.

Why this matters now

Lasix ONYU relies on the same premise, a wearable pump a patient operates at home, applied to intravenous diuretics that have stayed hospital-bound.

Sources

(14)
+8
PR Newswire Journal of the American College of Cardiology (ScienceDirect) Journal of the American College of Cardiology GP Cardiology University of Glasgow TCTMD Healio HCP Live SQ Innovation GlobeNewswire Medical News Stream PR Newswire JACC: Heart Failure Journal of the American College of Cardiology