StarTric

Transcatheter Tricuspid Valve Repair

MISSION

StarTric was founded by a small group of cardiovascular industry and clinical experts, including Prof. Michele De Bonis and Prof. Ottavio Alfieri, inventor of the “Alfieri-stich” edge-to-edge repair of the mitral valve.

Together they have introduced and pioneered the Clover technique, for the edge-to-edge surgical repair of the tricuspid valve.

StarTric aims to replicate the open-heart surgical Clover technique, very effective but applicable to only to a tiny minority of patients, with a minimally invasive device that can avoid the surgical risk and be as effective as the Clover itself.

StarTric’s mission is to provide a truly accessible, safe and effective treatment for Tricuspid Regurgitation (TR), a very serious need for millions of patients, which remains largely unmet also after the introduction of a first generation of minimally invasive repair and replacement devices.

Building upon this legacy, StarTric started the development of a transcatheter technology aimed at replicating the concept, the results and the outcomes of the Clover open heart technique, so to make it available to the majority of Tricuspid Regurgitation (TR) patients.

CLINICAL NEED

Tricuspid Regurgitation (TR) is a very serious and widespread cardiovascular disease. It consists of the failure of the Tricuspid heart Valve (TV), positioned between the right atrium and the right ventricle, to close properly during the systole.

This results in a reduced oxygenation of the whole body, causing symptoms seriously impacting the quality of life, and consequences such as atrial fibrillation, heart failure and death: mortality for patients suffering from severe TR is about 85% at 10-year after diagnosis, if untreated.

TR affects 0.4% of the whole population and 4% of that above 75 years of age, that is about 4 million patients in Europe and 70 million worldwide.

TRICUSPID VALVE (TV)

TRICUSPID REGURGITATION (TR)

PATIENT NEED

Tricuspid Regurgitation (TR) can be effectively treated by open-heart surgery.

However, only less than 3% of patients can undergo open surgery because of the very high operational mortality (8.8%) while the vast majority of them, in particular the more fragile ones, remain untreated.

The need for addressing TR at a reduced surgical risk, emerged in recent years, has prompted the introduction of a first generation of minimally invasive transcatheter repair technologies.

Unfortunately these technologies, often not originally conceived for the Tricuspid Valve (TV), have today proven to have serious limits in either indication or efficacy, clearly inferior to that of open surgery when applied: there remains a vast population of TR patients in need of a more effective, minimally invasive TV repair therapy that can be adapted to their specific anatomy and pathologic condition.

TECHNOLOGY

StartTric’s technology has been conceived to replicate, through a minimally invasive transcatheter device, the repair concept, results and clinical outcomes of the Clover open-heart technique. It consists of a device that can be safely implanted at beating heart by means of a transfemoral catheter.

StarTric is the first transcatheter TV repair technology based on a successful surgical technique conceived specifically for the tricuspid valve, unlike other repair technologies of first generation, in general derived from mitral valve devices.

StarTric can credibly combine the safety of a minimally invasive device with the efficacy of the Clover technique. Besides, its concept can make delivery easier and results more predictable, so to become truly accessible to most cardiology centers and to the vast pool of their patients, today deprived from therapeutic options that can adequately address their unique, specific needs.

Device currently under development and not available for clinical use

TEAM

Prof. Ottavio Alfieri

Inventor, Founder

Surgeon, scientist and innovator, his work made cardiac surgery history. He introduced the “Alfieri stich” for edge-to-edge mitral repair, at the base of the most used minimally-invasive repair device, the MitraClip.He has also pioneered the “Clover” technique for edge-to-edge repair of the tricuspid.

Prof. Michele De Bonis

Inventor, Founder

Head of Cardiac Surgery for Advanced Therapies and Research at San Raffaele hospital, he co-pioneered the edge-to-edge “Clover” tricuspid repair. His clinical and research activity significantly contributed to the progress of cardiac therapies, as a highly reputed expert of mitral and tricuspid valve repair.