PARIS (Reuters) - The artificial heart fitted in a patient who died on Saturday malfunctioned due to a fault with the controls of its motor, but an initial analysis indicates there are no fundamental problems with the device, its manufacturer Carmat said in a statement.
The patient, the second one to die while fitted with a Carmat artificial heart, suffered from a reduced flow of blood as a result of the malfunction, the company said.
But it pointed out that the patient lived “a virtually normal life” wearing the device for nine months, a period it said was long enough to demonstrate its biocompatibility with the patient’s body and blood.
“At this stage of the analysis, the design’s fundamentals have thus been corroborated,” it said.
Carmat added that further data “will provide an opportunity to pursue the expertise of the causes of the malfunction more proficiently”.
The company’s shares were suspended on Tuesday after news of the 69-year-old male patient’s death. A spokeswoman said she expected the suspension to be lifted on Wednesday.
Carmat is conducting trials of its heart device that is designed as a permanent implant to extend the life of patients without them having to wait for a human heart donor.
The company’s first transplant patient, a 76-year-old man, died in March last year, two-and-a-half months after his operation.
A third patient was fitted with a Carmat artificial heart on April 8.
Reporting by Andrew Callus; Editing by Ingrid Melander and Susan Thomas