France’s national device & drug agency, the Agence Nationale de Sécurité du Médicament, said late yesterday that “Carmat has provided the elements allowing for the resumption of the trial, meeting satisfactory conditions of safety and risk control.”
The ANSM suspended the the trial in December 2016 after a 5th patient died; in February Carmat said the patient’s death was not related to a problem with the device. The company rescinded its bid for resuming the trial to gather more data for the agency, before re-applying to start it up again. The 5th deceased patient was the 1st in the study’s pivotal phase; the ANSM said Carmat can implant the device in 5 more patients for the Phase III portion.
Carmat said it plans to expand the study to other nations and intends to open a new, more-automated plant to manufacture the device.
“The site should be operational by the end of the year and would also eventually enable the manufacturing requirements for the prosthesis’ 1st commercial launch phases to be met,” the company said.
Carmat in August 2016 launched the pivotal phase of the trial for the 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.
ALCAR shares were up 13.5% to €30.29 apiece ($33.05) today as of about 4 p.m. in Paris.
($1 = €0.916361)