At the end of March, Realheart started a series of long-term animal studies. Four surgeries have been performed – the latest one on June 21st – using a new remote technology and introducing a new surgical team. However, relaxed pandemic restrictions have led to a very high pressure on the animal lab and available surgery dates. As a result, Realheart will take a break in the animal studies and start the next series mid-September.
The number of surgeries in this study has been limited to one per month due to pandemic circumstances and travel restrictions. Now, as many companies want to restart their testing activities after long breaks during the pandemic, problems arise.
‘’Up until now, we have had no problems getting the times we want, but now when we try to book surgeries, there is a queue. We will therefore take a break and start the next series of surgeries after summer. On the other hand, this gives both our team and the surgical team some well-deserved time off,’’ said Realhearts CEO Ina Laura Perkins.
In the surgeries due to take place this autumn, the aim is to wake the animals up and test that they have normal functions for a certain period of time, while in the series that is now ending, the aim has been to educate and set processes. No animals have therefore been awakened after surgery.
The operations have provided a number of very valuable lessons. They were carried out with a completely new surgical team while Realheart's team participated remotely for the first time. A few problems with the remote technology occurred during the first operation, but these were resolved for further testing.
The new surgical team has now learned to implant the device and complete the operation on their own with a stable system. Realheart is focused on creating a product that is easier for surgeons to use compared to existing technology.
‘’During the learning process, we have identified several user factors that can now be documented and included in future manuals, which is exactly what this type of study aims to do. We are very pleased that the product has performed well and feel very confident about the next test series," said Ina Laura Perkins.
For more information please contact:
Ina Laura Perkins, CEO, at +46(0)70 406 49 21 or email@example.com
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)