A nano blood pump that saves a lot more heart patients

Dr Toshimasa Tokuno

, an expert in bio-medical engineering with a doctorate from the Rice University, Houston, USA and director, International Sun Medical Technology Research Corp, Suwa City, Japan, was recently in Chennai where he delivered a lecture on this new breakthrough technology named, ‘Evaheart’. M R Venkatesh of Deccan Herald spoke to him. 

What is the uniqueness of this ‘rotary blood pump’ which you call ‘Evaheart.’ Are there other labs working on similar devices?

This is a bio-compatible heart assist device that preserves and supports the functions of a natural heart. It is a kind of an artificial heart, an implantable blood pump that pumps out blood from the left ventricle and takes it to the aorta, enhancing the patient’s heart motion through continuous blood flow.

‘Thoratech’ of the US has commercialised a similar product after approvals from the Federal Drug Authority (FDA). But our’s is a wholly indigenous effort and we believe more patients, waiting for long years to have a heart transplant, can actually be saved by this device.

It has been conceived and patented by Dr Kenji Yamazaki, Tokyo Women’s Medical University.

How long has your lab been working on this and how is it bio-compatible?

We (Sun Medical Technology Research Corpn) have been working for 18 years now and spent a lot of money on it. As a medical device, it is very small, weighs 420 grams and fabricated by us in Japan in pure Titanium metal. It is placed above the diaphragm and does not generate any heat for the patient. It is not difficult to move around with this device that is connected to a controller outside that drives the pump-motor. The external unit can be easily carried in a backpack by any patient. The pump can theoretically last for ten years easily, but also depends on how the  individual patients keep it.

Is the unrelenting working culture of the Japanese causing more heart diseases from stress, prompting research on such devices?

No, I don’t think heart diseases are going up in Japan. More people are getting older in Japan, and the ageing factor perhaps is a cause for worry. This is despite the fact that heart-related diseases are the third major cause of deaths after cancer and strokes in Japan. In fact, the Japanese market for such devices is very small and so we have to necessarily go out to countries like USA, which is still the biggest market for medical devices.

But the real significance of R & D of such devices is that the number of yearly heart transplants depends on heart donors. In Japan, it averages less than ten donors every year, and so heart patients have to wait much longer for a transplant.

I believe similar is the situation in India with not enough people donating organs.
Hence, devices like ‘Evaheart’, as a ‘bridge to transplantation’, could save more patients who are dying of heart diseases, particularly where supply of donor organs is limited as in India.

How has your device fared in clinical trials in Japan?

In Japanese clinical trials, as on Dec 1, 2009, 18 patients whose mean age is 42 years have been enrolled for implanting ‘Evaheart’. The success rate we have achieved is two years survival in over 70 per cent of the patients, which is a good success rate.  But 18 cases  is a very small number and we need to do more clinical cases. We are also hoping to begin clinical trials of this device in the US in Feb/March 2010. We are selecting 15 medical centres in the US to do nearly 150 cases there, in line with the FDA norms.

‘Evaheart’ sounds queer and how does it synchronise with the natural heart beats?

No, we are not synchronizing its (device) working with the heart beat. What we have done is to keep the motor of the blood pump rotate at a constant speed of 1800 rpm. That takes care of all the requirements and it is a very simple control mechanism. The device’s inventor, Dr Yamazaki gave it the name ‘Evaheart’. ‘Eva’ has a meaning opposite of ‘Ego’. It stands for love, harmony and mutual good. Hence our device name is ‘Evaheart’.