Carmat announced on 2 May 2017 that it has obtained approval from the French regulatory agency (ANSM) to resume its pivotal trial for the Carmat heart. This follows a favourable review by ANSM of the actions and analyses taken by Carmat following the trial’s suspension after the death in October 2016 of this trial’s first patient six weeks after his implantation. Carmat maintained that the death was not due to a prosthesis malfunction, but due to poor handling of the batteries by
05 May 2017
Carmat obtains clearance to resume pivotal study
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Carmat obtains clearance to resume pivotal study
Carmat SA (ALCAR:PAR) | 0 0 0.7% | Mkt Cap: 195.7m
- Published:
05 May 2017 -
Author:
Pooya Hemami -
Pages:
2
Carmat announced on 2 May 2017 that it has obtained approval from the French regulatory agency (ANSM) to resume its pivotal trial for the Carmat heart. This follows a favourable review by ANSM of the actions and analyses taken by Carmat following the trial’s suspension after the death in October 2016 of this trial’s first patient six weeks after his implantation. Carmat maintained that the death was not due to a prosthesis malfunction, but due to poor handling of the batteries by