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CE Marking Tamilnadu

Patient Death Halts Carmat Trial

Carmat’s goal of obtaining a CE mark Certification for its artificial heart by the beginning of 2018 already looked ambitious; now it looks impossible. The French regulator ANSM has ordered the group to suspend implants of the device in its pivotal European trial following the death of the first patient in the study.

While regulatory caution is of course to be applauded, this may be a little harsh on the French company. The patients the heart is designed to treat are gravely ill, with a life expectancy of around two weeks. In this case, implantation of Carmat’s product allowed the patient to live at least a month.

The company’s shares initially fell by 29%, but have partly recovered and are now trading down 13% on yesterday’s close.

                                                                              –   03 Dec 2016

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