Introduction

Approxima is an implantable device for concomitant treatment of both tricuspid valve regurgitation (TR) and right heart failure (RHF) by ventricular reshaping. These pathologies have serious impact on mortality among population aged over 60. RHF is very often a consequence of TR related to the right ventricular progressive dilation and dysfunction. The state-of-the-art treatments have limited efficacy as they address only the effect of TR (leaking valve). To-date there is no therapy which targets both, TR and RHF.

Technical features

Approxima is a novel implantable medical device. The implant is delivered to the heart via established minimally invasive procedure using a dedicated delivery tool and the operator is guided by medical imaging under beating heart conditions. The device is composed by two anchors, placed on the opposite sides of the right ventricle, coupled by a tether. The approximation of the anchors displaces the ventricular walls and thus counteracts the ventricular dilation. Functional prototypes were developed and manufactured. Their efficacy was shown in an ex-vivo model (Jaworek et al., Structural Heart, 2020), and the implantation procedure was assessed in a cadaveric model. The technology has a TRL 4. The pilot in-vivo animal test will be performed in early 2022. First-in-man implantation is foreseen for 2025.

Possible Applications

• Treatment of the tricuspid regurgitation;
• Prevention of right heart failure;
• Treatment of right heart failure;
• Scale-up potential to mitral valve and left heart failure treatments.

Advantages

• Provide access to treatment for currently inoperable patients (>4M);
• Novel approach by right ventricular reshaping;
• Reduction of the tricuspid regurgitation;
• Stabilization of ventricular size and prevention of the right heart failure;
• Improvement of the ventricular contractile properties.