HeartWare International is clinging to the hope that the recent clinical pause of its MVAD mini heart pump will not mean a product redesign. If it does, in the words of its chief executive, Doug Godshall, "all bets would be off" as to when its halted CE mark study could resume.
Mr Godshall put on a brave face during a conference call to discuss HeartWare’s third-quarter results, adding that there was no evidence that a redesign would be needed. Nevertheless it will be a jittery wait for investors as it looks likely this will take a couple of months to determine either way.
CE mark pause
HeartWare first halted the trial in September owing to an issue with its controller, which it says it has now fixed. The modification does not require regulatory approval – it is not classed as a design change as it involved the way a circuit board is fastened inside the controller.
At the same time, the company also uncovered a software problem, which it says has no safety impact and is easily remedied. However, as this does involve a design change HeartWare will need to submit the upgrade to regulators, which it hopes to do in December. It should then take two weeks to a month for the new software to be approved, leaving the way open for the study to restart.
But these issues come on top of the more worrying adverse event reports, which emerged earlier this month and led to HeartWare’s shares tanking (HeartWare falls further behind with next-gen device pause, October 14, 2015).
Today’s conference call did not reveal any more details of these adverse events, but the overwhelming message from HeartWare was: we’ll restart the trial, we’re just not sure when. This will not be much consolation to investors, who have seen the group’s stock lose 40% of its value since the beginning of the year.
Lightning strikes twice
HeartWare believes that a similar experience with its now approved HVAD pump could help it here: it had to stop a study of the older device but was able to resume enrolment after finding a small amount of variability between pumps – the company put in place a device screening process to weed out those pumps that did not work so well.
“We’re hoping for an analogous situation with the MVAD,” said Mr Godshall – in other words, that a new quality control measure would be needed, rather than a complete device redesign. However, even if this is the case some might question why HeartWare did not learn from its previous mistake and employ a more rigorous screening process originally.
If there is a fundamental problem with the design this would spell disaster for HeartWare, which would have to stop the trial altogether and possibly even go back to animal studies, meaning a probable multi-year delay. The company is going through the MVAD data, so it will take some time to determine which of these outcomes will come to pass.
With St. Jude Medical pulling away with its newly CE-marked HeartMate 3 device, HeartWare will hope for the best-case scenario – otherwise it risks being crushed by its much bigger rival.