FDAnews Device Daily Bulletin

Artificial Heart Maker Eyes 2015 EU Launch

Nov. 19, 2013

French medical devicemaker Carmat hopes to wrap up clinical studies of its artificial heart in Europe in time for a 2015 launch date — with eyes on U.S. market entry sometime thereafter.

“We target 2015 for CE mark, and U.S. investigational device exemption would come only after commercial launch in Europe, unless opportunities present themselves in the meantime,” spokeswoman Caroline Carmagnol said Monday.

The device is designed to be a permanent heart replacement, “thanks to biological components” that reduce the risks of thromboembolism and bleeding and to the device’s auto regulation, Carmagnol added.

The first human implants were approved in May at four cardiac surgery centers in Belgium, Poland, Saudi Arabia and Slovenia. In September, Carmat also got a green light from France’s ANSM to implant its experimental heart in four patients at three approved French hospitals.

Carmagnol said the company is in talks with Johnson & Johnson, Medtronic, St Jude Medical and Edwards Lifesciences about a possible partnership to facilitate the regulatory pathway in the U.S. “All of these companies are aware of our device, [and] all of them have marked interest for surgical heart failure therapy,” she said, adding that due to the clinical development stage, little more can be confirmed. — Nick Otto

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.