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Pivot Extend®
 

Our permanent, flow-adaptive valve support for tricuspid regurgitation (TR)
— A permanent implant designed to restore coaptation and sustain heart function

through dynamic, self-centering support.

Pivot Extend®

Device Summary: Pivot Extend®

Intended Use

Definitive therapy for secondary tricuspid regurgitation

Target Disease​

Secondary tricuspid regurgitation

TR Severity Treated​​

TR inclusive of severe to torrential cases with a preference for massive to torrential TR

Target Population​

High-risk, frail, or inoperable patients with severe TR

Implant Duration​

Permanent​

Deployment Method​

Transfemoral venous access / transcatheter​

Removal​

Removable and reversible by transcatheter retrieval​

Anchoring​

Atraumatic non-fixated anchoring (IVC + PA)​

Spacer Design​

Self-centering oblong spacer with flow-adaptive saline-filled balloon

Spacer Materials​

Nitinol mesh structure, fully encapsulated saline-filled balloon​

Valve Interaction​

Supports leaflet coaptation without fixation or leaflet trauma​

Flow Preservation​

Spacer designed for hemodynamic flow around the device​

Adaptability​

Dynamic self-centering and adaptable to progressive cardiac remodeling​

Procedural Setting​

Percutaneous intervention; cath lab or hybrid OR​

Customization​

Spacer volume can be adjusted during procedure to fit patient-specific valve anatomy (12mm~20mm dia.)

Pivot Extend® Delivery 
 

Flexible, Transfemoral 
with In-Procedure Balloon Customization

Pivot Extend® is delivered through a transfemoral vein catheter system, introduced via the IVC and advanced into the right atrium under standard fluoroscopic guidance. The implant is positioned so that the saline-filled balloon spacer spans the tricuspid valve in an oblique orientation, secured by non-fixated anchors in the IVC and PA.

Unlike traditional fixated systems, Pivot Extend® uses flow dynamics and device geometry to remain centered and stable. The balloon volume is adjustable during the procedure to match the patient’s valve anatomy, enabling customized coaptation. The system does not require TEE or ICE guidance and allows for catheter-based retrieval
within 2–4 weeks if needed.

 

Access Site ​

Transfemoral venous access 

(standard percutaneous approach)​​

Delivery Path​

Femoral vein → IVC → Right atrium → Pulmonary artery

Deployment Orientation

Oblique positioning across the tricuspid valve

Proximal Anchor

Distal Anchor​

​Spiral structure within the IVC

Atraumatic extension into the pulmonary artery​

Spacer Design​

Saline-filled balloon

Nitinol mesh support​

Intra-Procedural Adjustment​

Balloon volume is adjustable during implantation /

Tailored to individual valve anatomy under fluoroscopic or echo guidance​

Imaging

Fluoroscopy-guided

No TEE or ICE required​

Retrievability​

Fully catheter-retrievable within 2–4 weeks post-implantation​

Est. Procedure Time​

~60 minutes

Learning Curve ​

Low; designed for rapid adoption by interventional teams

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