BACKGROUND: Heart failure is the leading cause of death for both men and women 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 valve regurgitation. The past decade has witnessed a revolution in the treatment of heart valve disease. For the aortic valve, patients no longer need to have their chest cut open and their heart stopped in order to have their valve replaced. While the same revolution is already on its way for the mitral valve, the tricuspid valve has remained largely forgotten due to unique functional and anatomical challenges. Although there are 550,000 new tricuspid valve disease cases diagnosed every year in the US and EU, less than 1% of these patients are treated. This is due to the fact that open-heart surgery is still the only treatment option, which is very risky. Without suitable treatment options, all that doctors can do is to manage their patients’ symptoms with diuretics. These patients face worsening quality of life and eventually die. The prognosis is bleak with 3 of every 5 patients dying within 3 years.
DUO SOLUTION: DUO is a minimally invasive device uniquely tailored to the anatomical challenges of the tricuspid valve. Designed by a leading interventional cardiologist, DUO is the only minimally invasive tricuspid valve that works in tandem with the native valve. 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 or the native tricuspid valve leaflets. The DUO-TF (Duo-transfemoral) device is a next generation device, designed to support delivery through a vein in the leg is the focus of the FTI project. Patients have restrictions that prevent transjugular delivery due to the size of the vein or the presence of a previously implanted devices. Additionally, it changes the procedure from one requiring general aesthetic to one where only local sedation is needed, minimising impact to the patient and increasing adoption.
FTI PROJECT: This FTI project will progress and finalise the development of the Duo device and enhance Duo’s profile by developing clinical evidence with the next generation device, demonstrating the clinical benefits to the patient. This consortium is a group of innovative and complementary SME’s that are uniquely positioned to undertake the activities necessary to accelerate the device to market and maximise penetration. The main goal of the project is to strengthen the position of Duo as the Gold Standard treatment for Tricuspid Regurgitation, thus saving the lives of thousands of patients suffering with this condition and reducing the high healthcare burden associated with their care.
