Heart Failure with preserved ejection fraction (HFpEF) is a life-threatening form of congestive heart failure condition annually affecting more than 25 million people globally. HFpEF occurs commonly in older individuals and has higher prevalence in women. As the European population is aging (over 65 accounting for 19.2% of the total European population, 2.4% more than 10 years ago), HFpEF will affect more and more people, representing significant economic and social challenge for the patients, their families and National Health Systems.
Currently there is no solution on the market for such heart failure condition. Though the effect of some drugs used in the treatment of HF with reduced ejection fraction are currently studied for HFpEF in large clinical trials (e.g. PARAGON-HF Trial, TOPCAT Study), a new approach based on the left interatrial shunting is needed.
The CorAssist introduces a “spring-like” metallic device, CORolla® for augmentation of diastolic function of the heart. The CORolla® is implanted inside the left ventricular of the heart in a minimally invasive procedure. The self-expanding, internal device harnesses the elastic energy during systole (contraction) state and releases it during diastole (relaxation) in order to augment dynamics of left ventricular relaxation and filling. CORolla® manages to impact directly and improve the impaired diastolic function, needing only one-time procedure.
CorAssist Cardiovascular has the vision to become the first company in the world to treat HFpEF. The EC grant is instrumental to this ambitious goal and company’s growth trajectory. Following a very promising validation in animals and humans, the company is planning to start first sales of CORolla® by the end of 2021.The SME Instrument project perfectly aligns with this objective, as it would provide the company with the financial resources necessary to complete the clinical study within the planned time-frame.
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