A clinical study by the Medical University of Vienna and Vienna General Hospital has demonstrated that Berlin Heals’ electroceutical device can exercise and strengthen the heart muscle in people with cardiomyopathy.
The implant delivers a microcurrent to stimulate cell regeneration in the affected heart muscle. This is expected to help patients avoid or delay heart transplant surgery.
In case of dilative cardiomyopathy, the heart muscle becomes pathologically enlarged and cannot contract sufficiently.
Currently, these patients are stabilised using drug treatment and then by technological approaches such as pacemaker systems. The last resort for terminal heart failure is heart transplant or ventricular assist devices.
The surgical procedure is said to be minimally invasive with the new microcurrent applicator. One electrode of the device is placed as a patch on the outside of the heart muscle, while the other is placed in the ventricle.
The implant then delivers a microcurrent to stimulate the damaged heart muscle and induces regeneration. It has undergone a range of preclinical tests.
In the latest in-human study, the researchers found initial signs of regeneration after three months in the first patient implanted with the device.
The study, which will enrol additional participants, is meant to validate the electroceutical device’s clinical significance and support its licensing process.
Study principal investigator Dominik Wiedemann said: “The preliminary findings bring us real hope for cardiomyopathy patients. Microcurrent regeneration could bring us a step closer to the dream of being able to regenerate damaged organs.
“Apart from heart replacement surgery, there are hardly any effective treatments available at present. Particularly in times when donor organs are scarce, it is important to develop new effective treatment techniques also to avoid major operations such as heart transplants as much as possible, as well as the subsequent immunosuppression that goes with them.”
According to the researchers, the device has been designed for patients who have exhausted drug treatment and other technological options but do not immediately require a heart pump or a transplant.