During the development of model 11, which is designed in two halves, we have, together with heart surgeons, seen new possibilities to use one pump half as a ventricular assist device. On May 4^th the we performed the first test to operate the Real Heart assisist device into a test animal.

 Up until now we have worked with a TAH product (Total Artificial Heart). This type of heart pump is used when the entire heart fails. A more common condition is when only one half of the heart fails. This type of failure can be temporary and can occur after e.g. an acute inflammation of the heart muscle. Patients with acute heart failure can be saved by implanting a ventricular assist device to support the failing half of the heart without removing the biological heart. A ventricular assist device is thus a smaller pump that works in coordination with the failing heart half, and supports it so that circulation is sustained at a sufficient level.

After a thorough assessment together with heart surgeons we took the decision to preform a first test  to insert a heart pump half model 11 as a ventricular assist. This operation was perfect.

For more information, please contact

Azad Najar, CEO
073-667 34 63
azad.najar@realheart.se
www.realheart.se

About Scandinavian Real Heart AB – Only approximately 5000 heart transplants are performed yearly in the world, and the supply of donor hearts is very limited. The need is great, and patients with heart failure die while waiting for a new heart. Scandinavian Real Heart is developing a heart pump (TAH) that mimics the body’s natural circulation, that will be possible to use as a temporary solution for patients waiting for a heart transplant.

We performed another animal operation with the heart pump model 11 on May 3^rd . This operation was successful and the pump functioned extraordinarily well, both mechanically and medically. The test showed that the heart pump could sustain a normal heart function at a stable level for a longer period of time on sedated animals.

As we have previously communicated, heart pump modell 11 is a competitive heart pump, type Total Artificial Heart (TAH), which replaces the deseased heart completely. Heart pump modell 11 fulfills all of the criteria that leading heart surgeons set up a couple of years ago. Additionally, it is the only heart pump (TAH) in the world that can beat with a pulse of 140-150 beats per minute. During the previous animal operations we have focused on tuning the surgical operation procedure. At the operation last week, we could optimize the care of the animal, and the animal functioned without complications also during the most sensitive period when implanting the heart pump. As a result of the test on May 3^rd, we now announce that we are ready to proceed to the next phase of pre-clinical trials on animals, i.e. survival tests.  

The result of this operation was so positive that we have decided, after a discussion with the surgical team, to cancel the operations that we had planned for June. We have thus decided the proceed immediately with the application to the animal ethics committee to obtain approval to perform survival tests. This means that the pump is implanted, and that the animal is then awakened from anesthesia. We hope to start these tests in Sweden in the beginning of this fall. We will, as previously communicated, visit Cleveland Clinic and Texas Heart Institute in Houston in the end of May. Primarily Houston has shown great interest in participating in the survival test project.

For more information, please Contact:

Azad Najar, CEO
073-667 34 63
azad.najar@realheart.se
www.realheart.se

About Scandinavian Real Heart AB – Only approximately 5000 heart transplants are performed yearly in the world, and the supply of donor hearts is very limited. The need is great, and patients with heart failure die while waiting for a new heart. Scandinavian Real Heart is developing a heart pump (TAH) that mimics the body’s natural circulation, that will be possible to use as a temporary solution for patients waiting for a heart transplant.