
The heart is the hardest working organ in the human body. For 24 hours a day, this mass of muscle tissue toils away to maintain a rich supply of oxygen and nutrients to our entire bodies. It is an anatomical marvel, but diseases affecting the heart are prevalent across the globe, and a huge amount of research is dedicated to improving the lives of patients suffering from these diseases.
For some patients suffering from chronic or acute heart failure, a heart transplant may be a final line of treatment in the most serious cases. However, it is no secret that waiting for a human organ that is a viable match for the patient can take many months or years, which is precious time the patient may not have.
It is therefore incredibly exciting to see that in recent weeks, an artificial heart developed by BiVACOR (US) has taken further steps towards FDA approval with an expansion of its clinical trials, and designation as a ‘Breakthrough Device’. This designation earmarks the device for acceleration of being brought to market following positive preliminary clinical data, which included successful implantation in a patient for 100 days prior to a heart transplant.
What is really exciting about this device is it is described as a ‘long-term’ replacement for a failing heart. The expectation is that it has the potential to replace the native heart for a significant period of time, and to possibly obviate the need for a transplant at all - a holy grail that would address the shortage of organs overnight. The medical device community will no doubt be keeping a close eye on further announcements over the coming months as the clinical trials progress!
For those interested in the technical details, the PCT patent specification can be found here.