A joyeux Noël for Carmat

When the French medtech Carmat told Evaluate Vantage in summer 2019 that it would submit an EU marketing application for its artificial heart by the end of 2020 the schedule looked rather ambitious. In fact the company was being unnecessarily humble: yesterday saw not a submission for the device but CE marking itself. The artificial heart may now be used as a bridge to transplant – keeping patients alive until a donor heart becomes available – in patients suffering from end-stage biventricular heart failure who cannot be treated with medical therapy or a left ventricular heart device, and who are likely to undergo heart transplant within six months of implantation. The achievement is all the more remarkable considering the fact that the European pivotal trial is still ongoing. Success in the first cohort of 10 patients was reported two years ago, but the second cohort will not yield data until next year. The lack of donor hearts is so pressing a problem that EU approval has been awarded on the basis of the device's showing in the first cohort. Launch will begin in the second quarter of 2021.

The history of Carmat's pivotal European trial
Date Event
Aug 29, 2016 Begins pivotal study
Nov 30, 2016 Suspends study after the first patient to receive the implant dies 
May 2, 2017 Resumes study in France
Oct 5, 2017 Expands study to Kazakhstan
Oct 13, 2017 Expands study to Czech Republic
Jul 11, 2018 Completes enrolment of cohort one
Jan 15, 2019 Presents positive interim results of the first part of the study; halts trial to change manufacturing process
May 10, 2019 Further delays production of prostheses from initial goal of April 2019
May 21, 2019 Resumes production of prostheses 
July 2019 Submits technical dossier to the notified body Dekra
Sep 3, 2019 Says it will make CE mark submission by end 2020
Dec 2, 2019 Gains approval to restart enrolment in Kazakhstan
Dec 9, 2019 Implants resume in Czech Republic
May 25, 2020 Implants resume in Denmark
Aug 6, 2020 Data on seven patients published
Sep 9, 2020 Says that Covid-19 restrictions will delay enrolment completion to Q1 2021
Oct 20, 2020 Gains approval to restart implants in France
Dec 22, 2020 Gains CE mark
Source: company communications.

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