PARIS – France’s medical device maker Carmat SAS said it has obtained the approval to proceed with the first human implantations of its artificial heart.
Cardiovascular diseases (CVDs) are the number one cause of death globally, said the World Health Organization (WHO).
“The number of people who die from CVDs will increase to reach 23.3 million by 2030. CVDs are projected to remain the single leading cause of death,” stated WHO. “9.4 million deaths each year, or 16.5 percent of all deaths, can be attributed to high blood pressure. This includes 51 percent of deaths due to strokes and 45 percent of deaths due to coronary heart disease.”
Carmat's bioprosthetic artificial heart
Carmat (Velizy Villacoublay, France) said it has received the approval to start testing its bioprosthetic artificial heart in human patients at four international cardiac surgery centers in Belgium, Poland, Saudi Arabia and Slovenia. In France, Carmat awaits the final regulatory approval from the drug safety agency, ANSM, to get started.
The four institutions, namely the St Pierre University Hospital (Brussels, Belgium), the Silesian Center for Heart Disease (Zabrze, Poland), the Prince Sultan Cardiac Center (Riyadh, Saudi Arabia), and the University Medical Centre Ljubljana (Ljubljana, Slovenia), are known for their surgical results and experience in innovative medical devices pre-market clinical trials.
Carmat said its implantable prosthesis consists of two, right and left, ventricular cavities containing two volume spaces each separated by a flexible bio-membrane, one for blood and one for the actioning fluid. A flexible external bag contains the actioning fluid and beats at the same rate as a native heart would.
Carmat's artificial heart integrates embedded electronics and multiple sensors
Carmat said an integrated electronic device regulates how the prosthesis operates according to patients' needs and using information given by sensors and processed by a microprocessor.
Operating details of Carmat's heart
Two motor pump units (A) alternately suck and inject a fluid into the ventricular cavities (B) thus moving the flexible biomembrane (C). When the hydraulic compartment empties, withdrawal of the biomembrane sucks blood into the ventricle. When it is filled up, the biomembrane pumps blood into the arteries. Biological admission (D) and ejection (E) valves ensure that the blood only flows in one direction.