On Wednesday, June 6, the third pre-clinical trial with Real Heart ™ was carried out.
We could this time wake up the test animal to a stable state with stable vital parameters, especially with regard to blood pressure and heart rate.
During two hours of observation after cardiac pump implantation, the parameters of the animal gradually improved. When the animal’s condition was stable with normal mobility and response, it was moved from the operating room to the stable. The stress associated with the move, caused a glue connection to that connects the aorta to the heart pump to get disconnected. A bleeding occurred which resulted in the study being discontinued.
“We do not consider this event to be a major problem. The glue connections have worked well in recent operations, but as they are subjected to strains when moving the test animal. We need to fix this until the next operation. We will instead suture the connections as we did in previous pig operations. “, says Azad Najar, CEO and innovator.
“The heart pump showed good performance after surgery and after a short while we could pump with full capacity. The new design on the air-vents worked well, but a further small adjustment is required. We can now vent the heart pump in an easier way to prevent the risk of air emboli, “continues Azad Najar.
In conclusion, after the third attempt, we now find that the operation technique works well, the solution for venting has improved and the heart pump delivers good physiological values. In future, we need to optimize some details throughout the pre-clinical process, especially around the critical post-implant period. New procedures for post-operative intensive care will therefore be developed.
For further information, please contact:
Azad Najar, CEO
E-mail: azad.najar@realheart.se
Tel: +46 (0) 736-673 463
This information is the information that Scandinavian Real Heart AB (public company) is required to disclose under the EU Market Abuse Regulation. The information was provided, through the above-mentioned contact person’s care, for publication on June 8, 2018.
About Scandinavian Real Heart AB – Only about 5,000 heart transplants are carried out annually worldwide, and the availability of donated hearts is very limited. The need is high and patients with heart failure die while waiting for a new heart. Scandinavian Real Heart AB develops a heart pump (TAH) that mimic the body’s natural circulation and can be used as a transitional solution for patients who are waiting for a heart transplant.