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 | |
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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. |