During the meeting with the American authority FDA during the spring, Realheart’s blood tests were discussed. These are a requirement to be allowed to perform clinical studies, since the tests investigate potential presence of blood damage. The company has now performed the first of several tests. The results show that Realheart TAH is gentler to the blood than a pump that is already commercialized.
One occurring side effect of heart pump implants is that red blood cells are damaged, which can lead to clotting. Therefore blood tests are a crucial factor when the authorities asses whether a company shall be allowed to perform clinical trials on humans.
During the year Realheart has developed custom built test rigs together with researchers, recruited personnel and cooperated with an European test lab to see how Realheart TAH affects blood. The first tests are performed and were done as a comparative study which compared Realheart TAH with a heart pump which is already on the market.
The result has now been analyzed and shows that the tested version of Realheart TAH causes less blood damage than the comparison pump. The study now continues with more comparative tests to extablish the exact effect that the TAH has on the blood.
”These results are in line with what researchers earlier have been able to conclude theoretically after performing computerized flow analyses. It is extremely pleasing that our unique design has performed well in these tests which show how gentle it is to the blood”, says Azad Najar, CEO and founder.
For more information please contact:
Azad Najar, CEO
Tel: +46(0)736-673 463
Scandinavian Real Heart AB develops a total artificial heart (TAH) for implantation in patients with life-threatening heart failure. Realheart TAH has a unique, patented design that resembles that of the natural human heart. The artificial heart consists of a four-chamber system (two atriums and two chambers) which provides the opportunity to generate a physiologically adapted blood flow that mimics the body's natural circulation. A unique concept in the medical technology world.