VisCardia
Active elderly couple jumping on a trampoline in a sunny backyard
visONE

Cardiac Diaphragm Support

The heart has a partner

Taking heart failure medications but still struggling? You may be eligible for RECOVER-HF, a clinical trial studying a therapy that uses your body’s own natural physiology to help your heart pump more efficiently.

Could I Qualify?How it works

For patients still searching for relief

Optimal Therapy.Still Symptomatic.Still Waiting.1

Still struggling despite your current treatment?

Heart failure medications and pacemaker therapy help many people—but for too many, symptoms continue.2 If that sounds familiar, you may be a candidate for RECOVER-HF, a clinical trial studying VisONE™ therapy.

You may qualify for RECOVER-HF

Talk to your cardiologist about whether this clinical trial could be right for you.

Learn About RECOVER-HF

How it works

See how VisONE™ delivers precisely timed diaphragmatic stimulation synchronized with the cardiac cycle.

Illustrative purposes only.

VisONE is implanted via a minimally invasive procedure

The VisONE system has two parts: an implantable pulse generator (IPG) and leads. The IPG is a small metal box containing a battery and electrical parts. It controls the rate of electrical signals sent to the diaphragm. The leads are flexible wires that send the electrical signal to stimulate the diaphragm.

If you enroll in the RECOVER-HF clinical trial, the device is implanted in the abdomen through a small, minimally invasive procedure that takes about an hour.3 The doctor makes two small incisions in your abdomen to access your diaphragm and insert the leads. The stimulator is implanted under the skin of your abdomen (similar to a pacemaker). The therapy stimulates a small section of your diaphragm muscle under your heart. You may be discharged on the same day or one to two days later.3 Your doctor will decide what’s right for you.

Minimal illustration of a torso showing the heart, diaphragm, two abdominal incision sites, and the VisONE implantable pulse generator
HeartDiaphragmIncision Sites
  • 12Incision Sites
  • Heart
  • Diaphragm

VisONE is an investigational device limited by federal law to investigational use.

No hardware implanted in the heart

Nothing is implanted in the heart.

Minimally invasive abdominal incisions

Minimal scarring, two small incisions in your abdomen to place the device.5

Comfortable stimulation patients do not feel

The stimulation is small, patients don't feel it.5-7

NowEnrolling

RECOVER-HF

IDE Pivotal Trial

Prospective, multi-center, double-blinded, sham controlled randomized safety and efficacy trial. ClinicalTrials.gov NCT06552637

Patient Population

NYHA II/IIIEF ≤40%QRSd ≤130mson GDMT

Could you qualify?

Not a complete list. Talk to your cardiologist to determine eligibility.

Early feasibility and clinical data across 150 patients6-12

How the diaphragm can support the heart has been studied in human subjects since 2009.10-12 More recently, 35 patients were implanted with VisONE in a study design very similar to RECOVER-HF.6-9 Over six months those patients demonstrated improvements compared to patients who did not receive therapy:

Increased activity levels

Improved Quality of Life

Minimally Invasive Implant

References

  1. 1Greene, Stephen J et al. JAMA cardiology vol. 11,3 (2026): 293-297.
  2. 2Heidenreich, Paul A et al. “2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure” Circulation vol. 145,18 (2022): e895-e1032.
  3. 3Goldberg, L R et al. Heart failure reviews vol. 30,5 (2025): 1035-1043.
  4. 4Salah, Husam M et al. Journal of the American College of Cardiology vol. 80,17 (2022): 1647-1659.
  5. 5Goldberg, L R et al. ESC heart failure vol. 9,3 (2022): 1677-1681.
  6. 6Fudim, Marat et al. JACC. Basic to translational science vol. 7,3 322-323. 4 Apr. 2022.
  7. 7Jorbenadze A et al. (2022) Struct Heart. 6(6):100103.
  8. 8Fudim M et al. (2025) RECOVER-HF Pilot Study: synchronized diaphragmatic stimulation for HFrEF therapy. Presented at THT
  9. 9Fudim M et al. (2026) Beyond the Heart and Nerves: Diaphragmatic Stimulation for HFrEF. Presented at THT
  10. 10Zuber, M et al. Congestive heart failure (Greenwich, Conn.) vol. 16,4 (2010): 147-52.
  11. 11Beeler, R et al. European journal of heart failure vol. 16,3 (2014): 342-9.
  12. 12Roos, M et al. Europace : European pacing, arrhythmias, and cardiac electrophysiology vol. 11,2 (2009): 191-9.