Tricuspid Regurgitation (TR) is a debilitating condition of the right heart valve that causes it to leak, making the heart work harder and leading to disease progression. Patients suffer with severe symptoms that drastically impact their quality of life and mortality. However, less than 1% receive treatment due to limited therapeutic options. The TR market is severely underserved and therefore offers significant market potential, estimated at €5Bn+ in the US and Europe alone. The objective of the 18-month grant program is the optimisation of the design to ensure the design is suitable for commercialisation and broad market adoption. This is to provide a wider treatable population and more scalable procedure, based on learnings from the feasibility clinical study, will ensure the potential of this groundbreaking design is realised.
The project is structured into 5 workpackages. WP1 consists of coordination activities to deliver the project results on time, to cost and to the expected contractual requirements. WP2 focuses on the design optimisation activities for the system. This is to provide a wider treatable population and more scalable procedure, based on learnings from our feasibility clinical study, will ensure the potential of this groundbreaking design is realised. WP 3 is the verification and validation testing necessary to support implementing these changes into the TANDEM II clinical study, followed by clinical validation. WP 5 covers the design control deliverables to ensure compliance with ISO 13485.
