PARIS (Reuters) - Artificial heart maker Carmat is hoping a more energy-efficient implant and the appointment of a production chief can help it overcome recent failures at the French firm.
Carmat won clearance from the French medicines agency to resume an implant trial in May after a suspension following the death of a fifth patient in October.
Chief Executive Stephane Piat, who took over in September, told Reuters that lessons from previous failures had been learned and Carmat was tightening its clinical trials procedure.
“There was a need to better oversee the clinical trial. We are in the process of doing that, and today everything is back to normal,” he said during an interview.
Carmat has hired Wenzel Hurtak, a Dutch national who has held top positions at U.S firm Johnson & Johnson, for the newly created post of director of manufacturing.
“This will enable us to separate production from research and development and better work on the future generations of our products,” Piat said.
Carmat says more than 100,000 patients in the United States and Europe could benefit from its artificial heart in the coming years, a market worth more than 16 billion euros ($18 billion).
The company hopes to bring its existing battery-powered product to market in the European Union from 2019.
The device is designed for people with end-stage heart failure, a fatal condition where the heart is unable to pump blood adequately around the body. It aims to be an alternative to heart transplants where there is a shortage of donor organs.
Privately-held SynCardia Systems and Abiomed, both U.S. companies, are among Carmat’s competitors, with SynCardia’s artificial heart the only one approved for use both in North America and the EU.
Piat said Carmat had been slow to develop a marketable product for a number of reasons but it expected to be able to develop prototypes more quickly using 3D printing.
“We are already working on a simpler, more energy-efficient heart,” he said.
The company, which has teamed up with tire maker Michelin and aerospace and defence group Airbus, has said it plans to open a new factory near Paris with more automated processes at the end of 2017.
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Editing by Andrew Callus and Alexander Smith