First-In-Human trials using the FLOWMAKER wireless flow accelerator are expected to start this year.
edical device company FineHeart has been awarded two patents by the China National Intellectual Property Administration for its fully implantable cardiac output restoration system FLOWMAKER.
The FLOWMAKER device is a fully intraventricular, rechargeable and wireless flow accelerator and is designed to address the unmet needs of patients with severe heart failure.
The new patents in China add to FineHeart’s international portfolio of 20 families and more than 78 patents for the concept, design, manufacturing and surgical implantation of FLOWMAKER.
Designed by French rhythm and electrophysiology cardiologists, the system is the first physiological heart assist device in the world for the treatment of patients suffering from severe heart failure.
A hybrid between a pacemaker and a cardiac assist device, the system enables the heart to restore its natural rhythm.
FLOWMAKER provides physiological support and restores normal blood flow while synchronising with the natural contractions of the heart.
The patents support the company’s strategy to provide a minimally invasive, effective implantable solution to patients with severe heart failure.
FineHeart chief science officer and co-founder Dr Stéphane Garrigue said: “Our miniature, mini-invasive, fully implantable left ventricular assistance system represents hope for thousands of patients with severe heart failure.
“With the FLOWMAKER, our ambition is to enable them to recover their vital functions and regain significant autonomy while freeing them from the constraints and complications associated with current devices or those under development.”
More than 300 million Chinese patients suffer from cardiovascular diseases, with severe heart failure affecting about 14 million.
FineHeart CEO and co-founder Arnaud Mascarell said: “We are extremely proud of being granted these patents in China, where the ageing population is facing a resurgence of cardiovascular diseases.
“It highlights the technological advances of our device and allows us to envisage an effective treatment for patients with severe heart failure in this country – once we have completed the clinical steps that will start soon. Our intellectual property portfolio is a key asset for our future development.”
FLOWMAKER is a miniaturised device measuring 10cm in size and can be used for the treatment of patients with varying degrees of severity.
The device reduces infection risk as it does not feature an external driveline and can be recharged via a wireless transcutaneous energy transfer system.
It is implanted by surgeons using a minimally invasive beating-heart procedure, which usually takes 90 minutes on average.
