Carmat (FRA:CXT) said yesterday that it won’t seek to resume implantations of its artificial heart after all, after French regulators suspended a clinical trial last fall after the 5th death in the study.
France’s national drug agency, ANSM, suspended the the trial in December 2016 after the patient died. Yesterday Carmat said the patient’s death was not related to a problem with the device.
“The patient’s death was due to an interruption in the power supply system, following incorrect battery handling by the patient, as a result of which the prosthesis stopped functioning,” the company said.
Carmat said it intends to float a new request soon after gathering more information for ANSM; the study is on hold until the French agency approves a new application.
“In France, innovation like the Carmat heart gets blocked, while it should be the fruit of strong collaboration between the authorities, the company, specialists, patients. … We are not on the same wavelength,” CEO Stéphane Piat said. “We have met with the American health authority, the FDA. They have a more pragmatic, more flexible approach.”
CXT shares closed down -3.5% at €27.78 ($29.68) per share today in Paris.
In August 2016, Carmat launched a pivotal trial of its bioprosthetic artificial heart, hoping to use the data to win CE Mark approval in the European Union.
Carmat’s 1st transplant patient, a 76-year-old man, died in March 2014, 2½ months after his operation. A 2nd patient died in May 2015, 9 months after receiving the transplant. Carmat said his death was due to a technical problem with the controls of the motor. A 3rd patient was fitted with the device in April 2015.
Material from Reuters was used in this report.