The World Health Organization estimates that 23.3 million people will die each year from cardiovascular disease by 2030, up from approximately 17.3 million in 2008. Organ transplantation is often the only treatment for end-state organ failure but the shortage of donors poses a huge problem for the NHS with demand for organs greatly exceeding supply. With the shortage of donors and increasing figures of CVD much research is being carried out to find a potential solution.
More than 30 years have passed since the first artificial heart was successfully implanted and these devices still provide a key temporary solution for those awaiting a transplant, providing a short-term solution for the patient until a suitable heart becomes available. The development of a new longer lasting synthetic heart has been subject to much research as its development would provide a remarkable breakthrough for modern medicine, lowering the need for heart transplants and saving thousands of lives in the process.
The French firm Carmat is working on doing just that and has designed a new artificial device that can replace the heart for up to five years, imitating the original organ through the use of biological materials and sensors. The product is designed to resemble a human heart, and is composed of two ventricles, each of which is divided by a membrane of calf tissue that has been sterilised and chemically treated.
Two motorized pumps contract the membrane, which in turn sends blood from the ventricles into the arteries in much the same way as a normal human heart. The device is embedded with sensors and other electronics which regulate this process and are powered by external lithium ion batteries that can be worn.
Carmat hopes to finish human trials on this artificial heart next year, ready for an EU launch by early 2015 if they obtain regulatory approval. Testing of the product has already begun; earlier this year they won approval to proceed with human implants in Belgium, Poland, Slovenia and Saudi Arabia.
In September, the French authorities approved implanting the device into four patients in several hospitals. The patients chosen for these preliminary implantations were selected as they suffer from terminal heart failure and have only weeks to live. The first range of tests focused solely on the devices safety, with success recorded on the bases of whether patients survive longer than a month of wearing the product. If these tests are deemed successful the devices will then be fitted into lower-risk patients and their effectiveness monitored over a six month period. Such devices provide an opportunity to fill the void created by organ shortages and present an exciting opportunity for future healthcare.