Reverse endoventricular artificial obturator in tricuspid valve position. Experimental feasibility research study

Area of Science:

• Cardiovascular Research
• Medical Device Engineering
• Animal Models

Background:

• Tricuspid valve regurgitation is a significant clinical issue.
• Current treatments for tricuspid regurgitation have limitations.
• Novel approaches for vena contracta space reduction are needed.

Purpose of the Study:

• To evaluate the feasibility and safety of a novel artificial obturator (REMOT) for tricuspid valve orifice reduction.
• To assess the long-term stability and tissue interaction of the REMOT device in an animal model.

Main Methods:

• Catheter-based implantation of the REMOT device in 7 sheep.
• Evaluation of device fixation using screwing wire and trans-apical anchoring.
• Assessment of device stability, tissue integration, and cell colonization using X-ray and morphological methods over 6 months.

Main Results:

• Successful implantation and fixation of the REMOT device in all sheep.
• The device remained stable in situ for over 6 months.
• Observed adhesion to tricuspid valve leaflets, specific cell invasion, and neovascularization of the REMOT body.

Conclusions:

• Catheter-based deployment of the REMOT obturator is feasible and well-tolerated in a short and long-term animal model.
• The REMOT device shows potential for vena contracta space reduction in tricuspid valve disease.
• Observed tissue integration suggests favorable biological response to the implanted device.