Nov 17, 2013

Carmat's Artificial Heart 'Available Soon'

Sky.com - A French firm hopes to finish human trials on an artificial heart by the end of next year, with it being made available for patients from early 2015.

Carmat also hopes to sign a deal with a partner in the United States, to gain access to the world's largest healthcare market.

Heart assistance devices have been in use for decades as a temporary solution for patients awaiting a transplant but Carmat's product is designed to replace the heart for up to five years, mimicking nature's work using biological materials and sensors.

It hopes to have the heart made available to thousands of patients waiting for a donor. In the past many people have died while waiting for a suitable replacement organ.

The company's chief executive, Marcello Conviti, told Reuters that it is already in contact with US firms, including Johnson & Johnson, Medtronic, St Jude Medical and Edwards Lifesciences.

Carmat estimates around 100,000 patients in the US and Europe could benefit from its artificial heart, which would make the market worth more than £10.25bn ($16.46bn).

In September, Carmat got the green light from French authorities to test the first human implants of the device on four patients in three hospitals.

Earlier this year, it also won approval to proceed with human implants in Belgium, Poland, Slovenia and Saudi Arabia.

"For now the tests are going as planned," Mr Conviti said.

He would not give details but said patients selected suffered from terminal heart failure and had only a few days or weeks to live.

On these high-risk patients, the first range of tests will focus on the device's safety, with success based on whether patients survive within a month of wearing it.

If deemed safe, the devices will then be fitted into lower-risk patients and their efficacy monitored for about six months.

"If all goes well, both phases should be completed by the end of 2014," Mr Conviti said.

He said that if the results were positive, the company hoped to obtain regulatory approval to launch EU-wide within two months.

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