World’s 1st completely artificial heart gets approval to be sold in Europe

By Rahul Vaimal, Associate Editor
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Carmat Artificial Heart Image
The Carmat artificial heart

Shares in France-based medical devices company Carmat posted their biggest gain in more than seven years after the company got approval to sell the first-ever total artificial heart in Europe.

This marks the culmination of a 27-year effort that began with a pitch from a French cardiac surgeon to an aerospace company.

The stock climbed 34 percent in Paris after rising as much as 50 percent, its steepest gain since May 2013. Carmat shares have advanced 66 percent this year, giving the company a market value of about $496 million.

Carmat received the CE mark for the device this week, which means that the company can now sell it in the European Union as a bridge to heart transplantation for patients with permanent end-stage heart failure.

Long effort

Surgeon and heart-valve inventor Alain Carpentier proposed development of an artificial heart to French industrialist Jean-Luc Lagardere in 1993. Mr Lagardere put a few labs and engineers from his Matra missile company at Mr Carpentier’s disposal and the project expanded over the years, including through the mergers that led to Matra becoming part of what is now Airbus. The planemaker is Carmat’s biggest shareholder, with a 13 percent stake, while Mr Carpentier owns about 5.3 percent.

It took 10 years for Carmat to obtain the CE mark, and “it’s a record, given the complexity of such a device”, Carmat chief executive Stephane Piat said. “We’ll have to work with doctors and medical centers now to offer our therapy and we’ll have to look for patients. The production phase will be a delicate one.”

In January, Carmat plans to speed up production of the device with a second shift, the chief executive, who took charge four years ago, said. Carmat’s artificial heart has blockbuster potential and could reap $700 million in annual sales in Europe by 2030, analysts predict.

“Everyone was waiting for it, and it’s here now,” experts said about the Carmat heart. “The CE mark is crucial for patients and the French company probably got approval for a blockbuster, given how large the medical need is and how rare and ineffective other solutions are.”

Carmat will start selling the device in the second quarter, the company said.