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So Far, No Sign of MVAD Needing a Redesign
HeartWare's management team offers more details on the paused CE Mark trial for its next-generation MVAD device.
Marie Thibault
October 30, 2015
3 Min Read
Marie Thibault
The good news on HeartWare’s next-generation left ventricular assist device (VAD), the MVAD, is that company executives haven’t seen any signs that the device needs a redesign. But it seems patients, investors, and onlookers will have to wait longer to get an all-clear signal on when the device’s CE Mark trial can resume enrolling patients.
That trial, designed to gather data to support a CE Mark, had implanted 11 patients before being paused in early September to allow for minor fix of a circuit board in the device’s external controller. In October, management announced that they had decided to investigate certain adverse events seen in some trial patients, and that the trial might not start again in November, as previously expected. According to the announcement, the adverse events are similar to those seen in other VAD trials and the company also investigated adverse events during it 2007 CE Mark trial for its HVAD device.
The LVAD maker’s management team dove deeper into specifics on the company’s October 29 earnings call. According to a Seeking Alpha transcript of the earnings call, Doug Godshall, HeartWare’s president and CEO, said, “We are encouraged by our initial findings from the clinical and technical review and presently, we do not see any evidence that a redesign will be warranted. We will have plenty of opportunities this fall to provide update as we progress back to the clinic.”
Godshall went on to explain that on the controller side, a solution for the assembly issue with the circuit board has been found, tested, and has passed validation, so controller production is restarting. In addition, the source of a bug in the controller software, which management said did not present a safety problem, has been found and a solution is being tested. A submission to the regulators, necessitated by the software change, is anticipated in early-to-mid-December.
On the adverse event side, Godshall said the company is looking closely at certain steps in the MVAD manufacturing process that may result in “a small amount of variability between pumps.” Godshall said, “If we determine that tightening certain specs will further improve pump performance, it is clear that we have the ability to measure and control our processes far better than what we have ever had in the past.”
Throughout the call, Godshall referenced the similarity to the company’s actions during the HVAD CE Mark trial. Describing the initial HVAD adverse events, Godshall said:
After our 14th patient, we had to pause enrollment to investigate some adverse events in a few patients. We restarted enrollment within a few months after implementing a more stringent screening process for our pumps and subsequently identified some tolerances in our manufacturing process that we tightened up, and which has served [us] exceedingly well ever since.”
Still, the company isn’t yet ready to give a more detailed timeline for a trial restart. Godshall said, “We’ll have to stay tuned before we can give you—give exact specificity on what we found, what we’ve changed, if anything, and when we’re going to restart the trial.”
Asked about clinician and FDA feedback on the MVAD, Godshall struck an optimistic tone, saying the “dialogue with the FDA is going very well” and that clinical investigators are “very excited about the device, both U.S. and internationally.”
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Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie.
[Image courtesy of HEARTWARE, INC.]
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