Five-year plan: Three stories from 2009

June 15, 2014 – 3:43 PM | By Mark McCarty | No comments yet
Take Five? Dave Brubeck five years before recording his best-selling single

Take Five? Dave Brubeck five years before recording his best-selling single

Sometimes it’s fun to revisit events in the past and see how things have changed in the meantime. Here are three stories that made the pages of Medical Device Daily five years ago.

2009’s drug balloons

Germany’s Nena sang of 99 red balloons in 1983, but TCT 2009 included a session on drug-eluting (or drug-coated) balloons. In the September 28, 2009, edition of MDD, I covered a discussion at TCT of whether the then-novel guidance for drug-eluting stents was of any value for developing drug-coated balloons (DCBs), and FDA’s position was – to put it succinctly – forget about it.

Some of the chatter at TCT that day addressed a balloon’s use as a way to deal with restenosis in an already-stented coronary artery, and there was little discussion, if any, of anything below the waist. But fast-forward to last week and you have a DCB tentatively indicated for the lower extremities, and not as a way to push back against restenosis in a stented artery.

The Lutonix DCB just aced an advisory hearing for the femoropopliteal arteries, but the label is going to say something like treatment of de novo lesion or restenosis of a previously ballooned vessel. I should point out that Lutonix has been at this since 2007, so it’s not a five-year plan from their perspective. They’ve also sold a lot more than 99 of their balloons in Europe, so…

Renegades at FDA

Most who read this blog surely remember the letters sent by members of the FDA review staff to the Obama administration (and to Congress) alleging malfeasance by senior member of the agency’s staff. I covered this story in the Jan. 12 edition that year, and this turned into a story about renegades.

“Renegades” was a word used when a now-departed member of the FDA staff described the situation to me in an off-record conversation, and events proved this FDAer right. Two of the authors of those letters, who were probably the ringleaders, found themselves without jobs when the agency declined to renew their contracts.

Managers at the agency resorted to tracking what these twerps did with their computers after it came to light that they’d sent proprietary device application data to Congress. But that was much later in the year, and the troublemakers who kept their jobs presumably have cooled their jets, all of which leads us to the third item on our agenda.

Shuren sworn in

Okay, so there’s no pomp and circumstance for getting the head honcho job at the Center for Devices and Radiological Health, but I have it on good authority that a lot of people at CDRH did not like how the agency handled the defenestration, as it were, of Dr. Dan Schultz from the CDRH director’s chair.

In comes Jeff Shuren, another MD (and a JD to boot), who formally took the job in August 2009. Shuren was at the helm when the surveillance of the renegades discussed above commenced, leading to the severing of the snake’s head from the rest of the corpus.

Since taking the job at CDRH, Shuren has suggested that European patients are guinea pigs (a comment about device lag he later retracted), and alleged that longer 510(k) review times were “all on industry,” another comment he had to walk back after Senator Richard Burr waved it in his face in a hearing on Capitol Hill.

On the other hand, Shuren has also overseen a much-needed re-engineering of operations at the Office of Device Evaluation, and pushed ODE staff to consider the possibility (gasp!) that not all patients have a low tolerance for risk. That might be a no-brainer for we the great unwashed, but it was apparently akin to a lifting of the veil for some of the Einsteins at ODE.

I have no doubt that many device makers have used swearwords in conversations about Shuren in the five years since he took the job, but he did get rid of a toxic mess at the radiological devices branch. For what it’s worth, I know for a fact there are at least a few device makers who spend a lot less time cussing as a result.


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