Clinical Need

For the hardest cases, few options exist.

Most patients with severe tricuspid regurgitation have no curative option, only symptom management. Pivot‑TR is designed to reach them, including patients with massive and torrential TR.

Tricuspid valve seen from the right atrium. With each heartbeat the annulus contracts and the leaflets close, but they fail to meet, leaving a central coaptation gap.
Coaptation gap. In TR the leaflets no longer meet during systole, and blood leaks back into the right atrium.

Tricuspid regurgitation

A valve that no longer closes.

The tricuspid valve sits between the right atrium and right ventricle. It closes tightly during ventricular contraction to keep blood moving forward.

In TR the leaflets fail to meet, and blood leaks backward with every beat. Over time this leads to right heart dilation, congestion, and heart failure. TR affects millions of people, especially older adults, yet remains widely underdiagnosed and undertreated.

Illustration comparing a normal tricuspid valve with a regurgitant valve Tricuspid Valve Blood leakingback intoright atrium Tricuspid Valve Normal closureTricuspid regurgitation
Normal valve compared with tricuspid regurgitation.

An underserved and growing population.

Significant TR affects roughly 1 in 25 elderly people.1 Despite high mortality, very few patients receive treatment that corrects the valve.

4.7M

Patients in Europe

with TR requiring treatment

2.5M

Patients in the U.S.

with TR requiring treatment

>30%2

One-year mortality

in severe TR, reaching about 50% at three years3

331k

New cases per year in Europe

approximate annual incidence

200k4

New cases per year in the U.S.

approximate annual incidence

<10k5

Surgeries per year

performed in each region

Symptoms and clinical impact

What patients with TR live with.

Symptoms often develop gradually and are easily mistaken for normal aging. Anyone who notices these signs, or finds that they are getting worse, should speak with a doctor for a thorough evaluation.6

  • Fatigue and reduced exercise tolerance

  • Shortness of breath

  • Swelling of the legs and feet

  • Liver congestion and ascites

  • Arrhythmias

If left untreated, TR can lead to

  • Right ventricular dysfunction and failure
  • Congestive heart failure
  • Atrial fibrillation and other arrhythmias
  • Cardiac arrest and sudden cardiac death
  • Increased stroke risk from thromboembolic events
  • Cutaneous changes: swelling, pigmentation, itching, bleeding
  • Progressively decreased survival over four years3
Grandparent spending time with a grandchildAdobe Stock preview · not licensed

Behind every number is a patient, and a family.

Current treatment leaves most patients behind.

Three approaches exist today. Each leaves a large share of patients, particularly the most severe and the most fragile, without a solution that addresses the valve itself.7

Medication

Treats symptoms, not the valve

Diuretics, blood pressure control, diet, and activity changes relieve congestion but do not correct valve dysfunction, so the disease can continue to progress.

Open-heart surgery

Significant risk for this population

Valve repair or replacement may be considered for select patients. The risk is often too high for elderly or high‑risk patients, and fewer than 10,000 procedures are performed per region each year.5

Transcatheter interventions

Eligibility limited by anatomy and condition

Catheter-based options avoid open surgery, but large coaptation gaps, complex valve anatomy, and patient fragility can still place many patients outside current therapies.

Why innovation is needed

Designed around the barriers.

The structural complexity of the tricuspid valve and the fragility of its patients call for a different approach. Each element of Pivot‑TR answers a specific reason patients go untreated.

BarrierHow Pivot‑TR is designed to respond

Massive and torrential TR

The largest coaptation gaps put the most severe patients outside most treatment options.

A spacer for the full severity rangePivot‑TR is designed to treat TR inclusive of massive and torrential cases, while remaining applicable to less advanced disease.

Frail and high‑risk patients

Many patients cannot tolerate open-heart surgery.

Transfemoral, with a temporary optionDelivered with standard catheter techniques. Pivot Bridge® offers temporary support that stabilizes patients and serves as a bridge to further therapy.

Changing anatomy

The right heart remodels over time, and valve geometry varies widely between patients.

Self-centering supportOblique, flow-guided positioning lets the spacer re-center dynamically as geometry changes.

Pacemaker lead‑induced TR

Leads crossing the tricuspid valve can hold the leaflets open, and lead extraction adds risk for patients who often cannot tolerate it.

Implanted with the lead in placeThe spacer restores coaptation from within the regurgitant orifice, without grasping leaflets or requiring lead extraction. Lead-associated cases have been treated this way under compassionate use, with the existing lead left in place.

RV dysfunction

A dilated, poorly functioning right ventricle limits treatment options, and fixing the annulus can restrict the motion that recovery depends on.

Non-annular contactPivot‑TR devices do not mechanically constrain the annulus, so right ventricular motion is preserved and the option for functional recovery stays open.

Treatment plans change

A permanent commitment is not always the right first step for a fragile patient.

Retrievable by designNon-fixated anchoring without sutures, clips, or tissue penetration allows retrieval through the same transfemoral route within a safety window of up to 3 weeks.

Pivot‑TR is an investigational device. Design intent is described above; clinical safety and effectiveness have not been established.

See how Pivot‑TR works.

A flow-aligned spacer, delivered transfemorally and anchored without tissue penetration.

Explore the technology View clinical evidence

Clinical Evidence

First-in-human results and the ongoing clinical program.

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News

Clinical studies, publications, and company updates.

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Get in touch

Clinical, partnership, and patient access inquiries.

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References

  1. Möllmann H, Weber M, Körber MI, Gößler TA-M, Ruf TF, Kempton H, et al. Focus on tricuspid valve—the European perspective. Eur Heart J Suppl. 2026;28(Suppl 4):iv70-iv82. doi:10.1093/eurheartjsupp/suaf099
  2. Nath J, Foster E, Heidenreich PA. Impact of tricuspid regurgitation on long-term survival. J Am Coll Cardiol. 2004;43(3):405-409. doi:10.1016/j.jacc.2003.09.036
  3. Samim D, Praz F, Cochard B, Brugger N, Ruberti A, Bartkowiak J, et al. Natural history and mid-term prognosis of severe tricuspid regurgitation: a cohort study. Front Cardiovasc Med. 2023;9:1026230. doi:10.3389/fcvm.2022.1026230
  4. Piscione M, Mroue J, Gaudio D, Mehta V, Matar F. Primary tricuspid regurgitation: from neglect to clinical relevance. J Pers Med. 2025;15(11):535. doi:10.3390/jpm15110535
  5. Seligman H, Vora AN, Haroian NQ, et al. The current landscape of transcatheter tricuspid valve intervention. J Soc Cardiovasc Angiogr Interv. 2023;2(6):101201. doi:10.1016/j.jscai.2023.101201
  6. Hahn RT, Adamo M, Fam NP. Current evidence on tricuspid regurgitation interventions in heart failure. JACC Heart Fail. 2025;13(8):102493. doi:10.1016/j.jchf.2025.04.008
  7. Minciunescu A, Emaminia A. Contemporary evaluation and treatment of tricuspid regurgitation. Front Cardiovasc Med. 2024;11:1350536. doi:10.3389/fcvm.2024.1350536