Realheart has signed an agreement with Hydrix to begin developing its clinical control unit – the device that future patients will need to be able to use safely in their own homes after having the Realheart total artificial heart implanted.
Hydrix is an Australian company that specialises in the development of control systems for heart pumps and artificial hearts and has a wealth of knowledge and experience in this field. Their platform has been used in many such systems and is characterised by a strong focus on the needs of the end user.
''Our current controller can run the heart in the way intended for laboratory studies, but when we want to move on to humans it needs to be transformed into a product that is highly user-friendly, safe to use and compliant with regulatory standards. By building the Realheart clinical controller on the Hydrix platform instead of developing our own, development time can also be significantly reduced,'' said Ina Laura Perkins, CEO of Realheart.
The importance of a robust user interface is also evident in the FDA's recalls of TAH products, the majority of which are due to problems in the interaction between the user and the device. Several deaths have occurred when the user misinterpreted alarms from the controller, disconnected cables and was unable to reconnect them.
''Alarms, switches, buttons, and displays must be easy to understand when the patient is using the product themselves without supervision. After all, we want our patients to have a good life with all that entails in terms of work, travel, exercise and playing with children or grandchildren”, said Ina Laura Perkins, and Magnus Ahlström, Hydrix Director Business Development in Europe, added:
“We’re very excited to be working with Realheart on this important project. We hope that our deep experience in controller design will improve quality of life of future total artificial heart recipients”.
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)