Pivot‑TR / Pivot Extend®

Permanent implant

Permanent support that moves with the heart.

Pivot Extend® is a permanent, flow-adaptive spacer for secondary tricuspid regurgitation, designed to restore coaptation and sustain heart function through dynamic, self-centering support.

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Pivot Extend® device renderAdobe Stock preview · not licensed
Pivot Extend®

Technology

A definitive therapy for patients with massive to torrential TR, sized in the procedure to fit each valve.

Pivot Extend® crosses the tricuspid valve obliquely, held between the IVC and the pulmonary artery without fixation. Flow dynamics and device geometry keep it centered, so support continues as the right heart remodels.

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Procedure

Designed to stay centered.

Delivered transfemorally under fluoroscopy, the spacer is inflated to the size the valve needs and then left to find its own center with every beat.

  1. 01Femoral vein
  2. 02Inferior vena cava
  3. 03Right atrium
  4. 04Pulmonary artery
12–20 mm

spacer diameter, set during the procedure

~60 min

estimated procedure time

2–4 weeks

window for catheter retrieval, if needed

Spacer volume is adjusted intra-procedurally to optimize coaptation.

Balloon inflation. Volume is adjusted from 12 to 20 mm during the procedure. Device rendering.
The spiral anchor stays fixed in the IVC while the distal anchor and spacer move with the heart, keeping the device aligned with cardiac motion. Device rendering.

Components

Three parts, no fixation.

Tricuspid valve IVC PA
Schematic, not to scale.

IVC anchor

A spiral structure in the inferior vena cava holds the proximal end without sutures, clips, or tissue penetration.

Benefits

Designed around the patient and the procedure.

Adaptive
Adaptive
Self-centering
Oblique, flow-guided positioning keeps the spacer in the coaptation gap.
Patient-specific sizing
Balloon volume is adjusted in the procedure, from 12 to 20 mm.
Follows remodeling
Designed to stay effective as valve geometry changes over time.
Atraumatic
Atraumatic
Non-fixated anchoring
IVC and PA anchors hold the device without sutures, clips, or tissue penetration.
Leaflet integrity
Supports coaptation without grasping or damaging the leaflets.
Retrievable
Designed for catheter-based retrieval if the treatment plan changes.
Accessible
Accessible
Transfemoral
Standard percutaneous venous access in the cath lab or hybrid OR.
Simple imaging
Fluoroscopy-guided placement, designed without the need for TEE or ICE.
Fast adoption
Designed for a short learning curve for interventional teams.
Short-axis view of the tricuspid valve with Pivot‑TRThe annulus expands and contracts with each beat while the spacer stays in the center of the orifice, clear of the annulus.AnteriorPosteriorSeptal
  • Tricuspid annulus
  • Pivot‑TR spacer
  • No-contact zone

Annulus Non-contact

Pivot-TR does not mechanically constrain the annulus, which may help preserve right ventricular function.

Older man gardeningAdobe Stock preview · not licensed

Designed for the patients other therapies leave behind: massive and torrential TR.

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Full specifications

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Intended use
Definitive therapy for secondary TR
Target disease
Secondary tricuspid regurgitation
TR severity treated
Severe to torrential, with a preference for massive to torrential TR
Target population
High-risk, frail, or inoperable patients with severe TR
Implant duration
Permanent
Deployment
Transfemoral venous access, transcatheter
Removal
Removable by transcatheter retrieval
Anchoring
Atraumatic, non-fixated anchoring (IVC + PA)
Spacer design
Self-centering oblong spacer with a flow-adaptive, saline-filled balloon
Spacer materials
Nitinol mesh, fully encapsulated saline-filled balloon
Valve interaction
Supports leaflet coaptation without fixation or leaflet trauma
Flow preservation
Designed for hemodynamic flow around the device
Adaptability
Dynamic self-centering, adaptable to progressive cardiac remodeling
Procedural setting
Percutaneous intervention in the cath lab or hybrid OR
Customization
Spacer volume adjustable during the procedure (12–20 mm diameter)
Imaging
Fluoroscopy-guided; TEE or ICE not required
Retrievability
Catheter-retrievable within 2–4 weeks after implantation
Est. procedure time
About 60 minutes
Learning curve
Low; designed for rapid adoption by interventional teams

Specifications as provided by Tau Medical. Investigational device, not commercially available.

Compare the two devices.

Pivot Extend and Pivot Bridge share one platform and differ in intended use and duration.

Device ComparisonPivot Bridge®

Clinical Evidence

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

See the evidence

News

Clinical studies, publications, and company updates.

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Get in touch

Clinical, partnership, and patient access inquiries.

Contact TAU MEDICAL