Friday, June 3, 2011

Fully implantable artificial heart ready for clinical trials

[caption id="attachment_5415" align="alignleft" width="300" caption="Coronary artery bypass surgery"]Coronary artery bypass surgery[/caption]

Michael Cosgrove - French biomedical company Carmat has developed a fully implantable artificial human heart which includes electronic sensors and biomaterials. The first implantation is scheduled to be carried out towards the end of this year.

Carmat was founded by professor and heart transplant specialist Alain Carpentier, who is the man who invented the heart and has overseen its development. He will also carry out the first implantation at the Georges Pompidou hospital before the end of the year. It will be judged to have been a success if it prolongs a seriously ill patient’s life by 180 days.

At 900 grammes, the device weighs twice as much as the human heart and it contains four valves, two atriums, a regulating system and two micro-pumps which circulate blood. The walls are covered in a micro-porous biosynthetic material which is designed to reduce the risk of blood clots.

The device uses sensors to regulate blood flow which imitate the way a natural heart works to detect whether the person using it is lying down, standing up or engaged in physical effort.

Once implanted, the heart is connected to a rechargeable battery which weighs several kilos and is worn around the patient’s waist and can be recharged using ordinary mains power or a car’s cigarette lighter. The device is also equipped with a telediagnostic system which is linked to a cardiology center 24 hours a day.

Carmat’s assistant managing director Patrick Coulombier says that “a heart in a thorax is like material installed in a satellite. It has to work autonomously for years on end and you need to reduce its weight, volume and energy requirements. It’s like a plane which takes off for the very first time because the first time a heart is installed it has to work.”

Over 100 million people suffer from cardiac insufficiency in developed countries and 100,000 of them are in need of a transplant, but only 4000 transplants are carried out each year. Less than 350 transplants are carried out each year in France although the total need is for between 1500 and 2000 hearts.

If clinical trials are successful Carmat will have access to a market potential of €16bn. The company hopes to be able to account for 10% of the market in a few years. The heart will cost €160,000 out of a total implantation cost of about €250,000, which is less than the price of a transplant, which stands at €268,000. Also, many transplant patients require several operations after the initial transplant.

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(This article is an English adaptation and translation of a French press article from French daily Le Figaro. It was done by Michael Cosgrove for publication on Le Figaro.)