The mood was pretty somber going into Heartware’s (Framingham, Mass.) breakout session during the 34th annual J.P.Morgan Healthcare conference. But why wouldn’t it be? It’s not everyday that a med-tech CEO has to discuss halting a European trial on one of its most promising technologies.
But that’s exactly what Doug Godshall, Heartware president/CEO did. Godshall, who took the leadership position of Heartware in 2006, delivered the bad news across a sea of somewhat disenchanted faces during the conference. He did a great job, but honestly, is there ever a “good way” to deliver bad news?
You see, Godshall revealed there were thrombus complications with MVAD that occurred in late December, causing the company to once again pause its CE-mark trial. Heartware's MVAD pump is a continuous axial flow pump. The MVAD trial is a prospective, non-randomized, single-arm study, that began in July. The trial will be implant patients with the MVAD pump via sternotomy or thoracotomy, with a primary endpoint of survival at six months.
The thrombus complications that occurred during the trial are from sustained suction that stem from Qpulse, a software algorithm that periodically regulates the speed of MVAD to promote aortic valve opening during left ventricular support.
And it should be pointed out that those December complications – well they come on the heels of Heartware pausing the MVAD trial back in September. The study was initially paused to allow for a minor circuit board fix for the device's external controller.
Now the company is in the process of exploring a few options. It can tinker with the algorithm; or it can do a redesign of the MVAD. There is no real concrete timetable for this but Godshall said it would take a minimum of 18 months to get back into the clinic if a design change was needed for the device.
What makes this pill even harder to swallow is that it’s chief rival in the space, Thoratec Corp. (Pleasanton, Calif.) is being integrated quite nicely after it was acquired by St. Jude Medical Inc. (Rochester, Minn.) for $3.4 billion.
During St. Jude’s presentation at J.P. Morgan, it’s CEO Michael Rousseau spoke up about the Thoratec acquisition and spoke about its reasons to go for Thoratec.
"We saw a technology and we liked it," Rosseau said of Thoratec’s Heartmate. "We thought Heartmate data looked really good. "We thought there were a lot of questions marks in Heartware’s [data]. We think the Thoratec acquisition was the right decision."Ouch.
The only bright spot for Heartware is that it is on track in its bid to secure a destination therapy (DT) indication for the HVAD system based on positive trends observed in the ENDURANCE2 trial. Heartware said it could submit to the FDA for approval in mid-2016. That could be a tremendous boost to the company, and help offset some of the bad news surrounding the MVAD trial.
[caption id="attachment_4504" align="alignleft" width="234"]Detention; it's supposed to hurt![/caption]
Device makers like to grouse about FDA, but they're not the only ones who feel they have an axe to grind. Recent warning letters suggest the agency is more frequently making use of detention to deal with violative products of all kinds from all kinds of places outside the U.S., but do the data support that idea? Let's peruse the FDA warning letter database to find out.
Can you say 'quadruple'?
According to the FDA warning letter search tool, the agency applied detention to 16 OUS companies in 2015 (the list includes only 15 when you use the search tool, but it appears to omit the Dec. 29 warning to Sorin, which as of this writing still appears on the recent warning letters webpage). That's up by quite a lot from each of the two previous years, when the agency hit only four firms with detention, and from 2012 when FDA slapped detention to five recipients of warning letters. Only two companies were hit with detention in 2011, but you get the point.
In contrast, a search with the term "quarantine" – the term used to describe the agency's sequestering of domestically manufactured products – yields exactly zero hits for 2015, a marked contrast to the seven warning letters in each of 2014 and 2013 that mention quarantine. I'll readily grant that the numbers I'm citing do not address other sources of data on similar actions, such as import refusal and so on, but these numbers address detention and quarantine on the basis of inspectional findings, and hence suggest the agency's policy has somehow changed.
Those who were following FDA's regulation of devices around the turn of the century will probably remember a set-to between regulatory attorney Larry Pilot and then-CDRH director David Feigel about the comparative rates of detention and quarantine. It'd be interesting to get the two of them in a room together now and hear what they have to say.
Whine with that cheese?
From time to time, I get calls and e-mails from device makers complaining about my use of words that appear in FDA's dictionary, but it's even more delicious when these companies hire public relations agencies to help out in that effort. It doesn't happen frequently, but this seems as good a time as any to address this peculiar phenomenon.
Whenever this happens, my first reaction is to advise the caller that the medical device business is an inherently controversial business. If you don't like controversy, may I suggest something a little more touchie-feelie, like the petting zoo business?
My second reaction is to advise the aggrieved party that I'm not responsible for FDA's regulatory terminology. If you have a problem with the agency's lexicon, do call them, but I have to say that kind of reaction comes across as that of a novice. I never get that from those who I know for a fact are experienced in the device business.
In any event, a device maker would be much better off dealing with whatever it is that got them in trouble with government in the first place. People in the PR business are happy to take your money to call me and e-mail me about FDA's use of the language, but you and I both have better things to do, don't we?