First Artificial Heart Approved For Sale in Europe

• Considered the world’s most advanced total artificial heart, it serves as a bridge to heart transplant for patients suffering from end-stage heart failure.
• It took 10 years for Carmat to earn the CE mark for a 27-year project.
• The artificial heart could reap 700 million euros in annual sales in Europe by 2030.

French company Carmat has just received approval to sell the first-ever total artificial heart in Europe. Considered the world’s most advanced total artificial heart, it serves as a bridge to heart transplant for patients suffering from end-stage heart failure.

It took 10 years for Carmat to earn the CE mark for a 27-year project, which started out as a pitch from surgeon and heart-valve inventor Alain Carpentier to French industrialist Jean-Luc Lagardere in 1993.

Lagardere, who owns the Matra missile company, provided laboratories and engineers for Carpentier to use for the development of the artificial heart. The venture expanded through the years and now Matra is Carmat’s biggest shareholder.

“It’s a record, given the complexity of such a device. 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,” said Carmat Chief Executive Officer Stephane Piat.

Piat, who took over the company as CEO four years ago, said that Carmat plans to create a second shift this month to ramp up the manufacturing of the device.

“As early as January, we will accelerate the ramp-up of our manufacturing activities and intensify discussions with our core target customers in order to achieve a smooth commercial launch during the second quarter of 2021, and thus offer a solution to many patients waiting for a heart transplant,” she added.

According to Portzamparc analyst Mohamed Kaabouni, the artificial heart could reap 700 million euros in annual sales in Europe by 2030.

“Everyone was waiting for it, and it’s here now. 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,” Kaabouni said.

The approval for sale caused Carmat shares to jump 34% to 32.05 euros (nearly 28.7 euros) in Paris in late December. Shares have advanced to 66% this year, making Carmat’s market value to reach 407 million euros ($496 million).