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Background and Importance Severe tricuspid regurgitation (TR) is a condition with major clinical impact, associated with disabling symptoms, recurrent hospitalisations, and poor prognosis. Conventional therapeutic options are limited: medical therapy mainly has a palliative role, while cardiac surgery is reserved for a minority of patients due to high operative risk. The advent of transcatheter techniques has expanded therapeutic opportunities. Among these, the EVOQUE system (Edwards Lifesciences, ) is the first CE-marked device specifically designed for transfemoral tricuspid valve replacement, offering a less invasive option for patients with severe symptomatic TR not suitable for surgery.Aim and Objectives This study aimed to describe the structured technical and scientific evaluation process that led to the introduction of the EVOQUE system into clinical practice, analysing clinical, organisational, and sustainability aspects.Material and Methods A multidisciplinary evaluation was conducted to assess the device’s technical characteristics, intended use, and clinical rationale, together with the available evidence from pivotal and early feasibility studies. The assessment included expected impacts on care pathways, resource requirements, and procedural logistics. Particular attention was given to defining patient selection criteria, team training needs, and follow-up parameters to ensure consistent procedural quality and monitoring of post-implant outcomes.Results In the first five patients treated, the EVOQUE system was successfully implanted, confirming the clinical and procedural feasibility of the technique. Considering the complexity of the procedure and the economic impact of the technology, an innovative outcome-based model was introduced: from the eighth implantation onwards, the device payment is linked to achieving an intra-procedural clinical outcome, defined as a reduction of tricuspid regurgitation to ≤ grade 1 confirmed by echocardiography. If this target is not met, a predefined adjustment is applied. This outcome-based approach, applied for the first time to medical devices within a regional governance framework, allows the adoption of high-value technologies while ensuring structured monitoring of effectiveness and economic sustainability.Conclusion and Relevance This experience demonstrates that innovation can be integrated with safety, appropriateness, and sustainability through a structured evaluation and monitoring pathway. Hospital pharmacists play a central role by linking clinical and technological evaluation with economic management, supporting the rational and effective introduction of advanced medical technologies for patient benefit and the healthcare system.Conflict of Interest No conflict of interest