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TREATMENT APPROACH

- Heterotopic
Tricuspid Valve Replacement

 

  • Minimally invasive transvenous access
  • Endograft with laterally integrated valve element
  • Anchored in superior and inferior vena cava
  • Designed for easy procedure and short implantation time

Product Description

is a novel treatment approach for severe tricuspid regurgitation.

is a minimally invasive, catheter-based treatment alternative for patients who cannot be adequately treated with medication and for whom surgical treatment is not an option.

consists of a delivery system, a bioprosthesis and a loading device.

The bioprosthesis is inserted into the vena cava by means of a delivery system and released in the vena cava. It is anchored in the superior and inferior vena cava and the laterally integrated valve element prevents the backflow of blood into the venous system caused by the insufficiency of the natural valve.

 

Application

The implantation of the bioprosthesis is done with a delivery system into which the bioprosthesis is loaded before the procedure. The catheter is advanced to the right atrium via femoral venous access. The prosthesis is aligned using radiopaque markers that clearly indicate the orientation of the valve element. The self-expanding bioprosthesis is released by pulling back the outer sheath of the delivery system.   The delivery system is designed to release the bioprosthesis in a controlled, gradual manner. The delivery system also allows the bioprosthesis to be re-sheathed or pulled back into the delivery system if the positioning of the bioprosthesis is unsatisfactory. This ensures precise positioning and a safe procedure.

 

The bioprosthesis replaces the function of the native tricuspid valve with its lateral valve element in the right atrium and the sealing of the superior and inferior vena cava. The valve leaflets of the TRICENTO bioprosthesis close during ventricular systole, thereby preventing the backflow of blood into the venous system and the associated symptoms.

The aim of the treatment is to restore forward blood flow in the heart and a pressure gradient between the heart and the vena cavae.

The self-expanding exoskeleton consisting of a nickel-titanium alloy fixes and seals the bioprosthesis in the superior and inferior vena cava with specifically defined oversizing. Therefore, the bioprosthesis is designed by precisely measuring the patient's anatomy.

 

Bioprosthesis

  • Endograft with lateral valve element
  • Self-expanding Nitinol exoskeleton
  • Porcine pericardium
  • Gold X-ray marker
  • PTFE suture material
  • Anchoring in superior and inferior vena cava

Endograft

  • Total length from 95 to 135 mm
  • For atrium lengths from 40 to 80 mm
  • Specially developed stent design consisting of Z-stents and longitudinal struts
  • Selected biological prosthetic material

X-ray marker
For orientation during release and alignment of the valve element

 

Anchoring / sealing zone

  • Anchoring in the superior vena cava
  • For vessel diameters from 16 to 35 mm
  • Required landing zone ≥ 20 mm

Bicuspid valve element

  • Prevents backflow of blood into the caval system
  • Responsive closing behavior low pressure gradients
  • Allows unidirectional flow
  • Allows potential downstream intervention

Anchoring / sealing zone

  • Anchoring in the inferior vena cava
  • For vessel diameters from 16 to 35 mm
  • Required landing zone ≥ 10 mm

delivery system

  • 24 F catheter system with integrated sheath
  • Squeeze to release mechanism for gradual release
  • Safety stopper for controlled release of the bioprosthesis
  • Tactile marker for pre-alignment of the bioprosthesis during the insertion process

PRODUCT VIDEO

– Treatment of severe Tricuspid regurgitation