Clinical Need
For the Hardest Cases:
Massive and Torrential TR
Pivot-TR is specifically designed to address TR inclusive of massive or torrential cases —
the most severe forms of the disease — where few treatment options currently exist.
Its adaptable design also enables effective treatment of patients with less advanced TR, providing broad clinical applicability across the spectrum of tricuspid regurgitation severity.
Today, most patients with severe tricuspid regurgitation have no curative options — only symptom management through medications.
Pivot-TR offers a new, minimally invasive pathway to directly address the disease at its source.
Limitations of Current Treatment Options
Tricuspid regurgitation is most often managed with medications and lifestyle changes aimed at relieving symptoms — not correcting the underlying valve dysfunction. These include diuretics, blood pressure control, dietary adjustments, and activity moderation.
For select patients, surgical valve repair or replacement may be considered. However, these procedures carry significant risk and are often not suitable for elderly or high-risk patients.
Why Innovation Is Needed
The structural complexity of the tricuspid valve and the fragility of its patient population demand new solutions:
• Minimally invasive options
• Adaptable to anatomical variability
• Safe for use in high-risk patients
• Designed for reversibility or staging
Pivot-TR is designed to address an unmet need.
Severe TR is linked to high mortality, yet fewer than 10,000 surgeries are performed annually in the U.S. and Europe, leaving a large population without adequate treatment. (NCBI.nlm.nih.gov)
What is TR?
The tricuspid valve, located between the right atrium and right ventricle, helps regulate blood flow by closing tightly during ventricular contraction to prevent backflow.
Tricuspid Regurgitation (TR) affects millions worldwide, especially older adults. It occurs when the valve doesn’t close properly, causing blood to leak backward. Over time, this leads to right heart dilation, congestion, and heart failure symptoms — yet it remains widely underdiagnosed and undertreated.
Normal
TR
Symptoms and Clinical Impact
Patients with TR may experience:
• Fatigue and reduced exercise tolerance
• Shortness of breath
• Peripheral edema (leg swelling)
• Ascites (fluid buildup in the abdomen)
• Liver congestion
• Arrhythmias
If left untreated, TR can worsen and lead to:
• Right ventricular dysfunction and failure
• Congestive heart failure
• Atrial fibrillation (AFib) and other arrhythmias
• Cardiac arrest and sudden cardiac death
• Increased stroke risk due to thromboembolic events
• Cutaneous symptoms:
swelling
pigmentation changes
itching
bleeding
• Progressive decreased survival over a 4-year period (NCBI.nlm.nih.gov)
An Underserved and Growing Population
• Significant TR affects approximately 1 in 25 elderly individuals*
• 4.7 million patients in Europe, 2.5 million in the U.S. require treatment.
• Annual incidence: ~331,000 (EU) and ~217,000 (U.S.)
• Yet, fewer than 10,000 surgeries are performed in each region per year.
• TR is frequently undertreated — Despite one-year mortality exceeding 30% for patients with severe TR and reaching ~60% at three years.
(*NCBI.nlm.nih.gov)