Realheart is developing the world's first artificial four-chambered heart. The research and development work are conducted using three different methods: digitally, in the laboratory and through anatomical and animal studies. In September, the long-term animal studies continue after a break during the summer, while digital tests and laboratory studies continue in parallel.
Digital studies include virtual implantations in 3D models based on real patients – an altogether new way of working in medical technology and one that Realheart is the first user to try – in collaboration with German Virtonomy.
Laboratory studies among many other things include blood tests with the Karolinska University Hospital, performance studies via a hybrid simulator at KU Leuven, blood flow analysis in 4D in collaboration with Linköping University and sustainability studies carried out at Realheart's own laboratory in Västerås.
Long and short-term studies with sheep take place at the Medanex Clinic in Belgium. In the previous series conducted before summer, a remote technology was implemented that allows Realheart's team to participate in surgeries without being physically on site. A new surgical team was trained and they have now learned to implement the product independently.
''This provides optimal conditions for further studies and our product has worked well throughout," said Ina Laura Perkins, CEO of Realheart.
A new series of surgeries will start in September and continue until the end of the year, when the results and conclusions are to be compiled. A number of surgeries may also be performed during spring as a way to keep the team's skills strong and up to date.
Meanwhile human anatomical studies are being conducted in collaboration with Professor Bart Meyns of KU Leuven as one of many preparations for human clinical trials.
''Animal studies are often given a lot of focus, but the other elements are just as important for us in order to move forward and, eventually, gain market approval,'' said Ina Laura Perkins, CEO.
For more information please contact:
Ina Laura Perkins, CEO
Phone: +46(0)70 406 49 21
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.Release (PDF)