Duo: A minimally invasive device to treat all patients with tricuspid valve disease

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Heart failure is the leading cause of death, affecting 15 million patients across Europe and the US. In patients with heart failure, the right heart expands, resulting in the tricuspid valve not closing properly and blood leaking backwards. This is called tricuspid regurgitation. The tricuspid valve has remained largely untreated due to unique functional and anatomical challenges. Currently less than 1% of patients are surgically treated due to the fact that open-heart surgery is still the only treatment option and is very risky. As a result, these patients face worsening quality of life with 60% of patients not surviving past 3 years. The Duo project aims to enable the commercialisation of a minimally invasive device that restores the function of the tricuspid valve in a safe and effective manner for all patients with TR. An innovative adjustable anchor holds the device in position between the tricuspid valve leaflets, anchored against the venous wall, where it does not touch the fragile cardiac tissue. This multi-disciplinary consortium of innovative SME’s is uniquely positioned to accelerate bringing this disruptive technology to market. CroiValve, the consortium coordinator, was founded specifically to develop and commercialise a minimally invasive tricuspid treatment. ICS Medical is an expert in the design, development and manufacturing of complex catheter solutions. Syntactx is a full-service CRO that understands how to deliver efficient and good quality clinical data. 3D LaserTec is an innovation driven centre for laser cut parts. With Fast Track to Innovation funding, the consortium will finalise the development of the Duo-TF device and develop US clinical evidence demonstrating the clinical benefits of Duo to the patient. This will position Duo as the gold standard treatment, thus saving the lives of thousands of patients and reducing this significant healthcare burden. The project will also enable Europe to take the lead in the large tricuspid €2.5Bn/year market.