The news at ACC 2017 has varied by product type, including TAVR devices, coronary artery stents and imaging modalities, As usual, there are potential and verifiable winners and losers, and in some cases, companies playing catch-up with the competition in an effort to take the lead, but this meeting is never boring.
FDA says ‘what embargo?’
In one of the more interesting stories at ACC 2017, the FDA broke an embargo regarding 25-month data for the Absorb GT1 coronary artery scaffold by Abbott Vascular. The agency advised clinicians of the higher-than-expected rates of major adverse cardiac events seen in the new data set from Absorb III, but two leading clinicians indicated they are not ready to jump ship on the GT1.
Antonio Colombo said he sees the glass as half full and half empty where the GT1 is concerned, and recommended that operators stick with the guidelines where pre- and post-dilatation are concerned, although he also recommended the use of intravascular ultrasound. Roxana Mehran was less forgiving of the news, but indicated no explicit aversion to the GT1 until a better unit arrives. The bottom line seems to be that operators need to tighten things up for their patients who want a device that isn’t a device after 36 months.
‘Instant’ improvement over FFR alleged
Can functional flow reserve (FFR) be bested by instant wave-free ratio (iFR) for determining whether a patient ought to undergo some sort of treatment for coronary artery disease? That’s a question taken up by two studies appearing at ACC 2017, including the Define Flair study, which set out to demonstrate the non-inferiority of iFR for MACE (a composite of death, MI and unplanned revascularization) compared to FFR.
Define Flair suggested that iFR led to fewer PCI and bypass procedures, and this approach eliminates the need for adenosine to boost blood flow, a necessity in FFR. Another advantage is that it shaves about four minutes off procedure time compared to FFR, which might not seem like much, but which might get hospital administrators at high-volume sites off the fence if the up-front cost isn’t too dear.
It’s a no-brainer that payers are sure to respond if iFR can keep up with FFR in terms of outcomes and beat FFR in terms of cost, and any perception that iFR eliminates needless revascularization would clinch the deal outright. A win for iFR would be a big win for Volcano Corp. and its new parent company, Philips.
Medtronic ‘skirts’ the PVL problem
Just take your latest transcatheter aortic valve device and slap a wrap around the bottom, and what do you get? A skirt that tamps down on paravalvular leak, or so that’s the message from Medtronic, which released 30-day data for the Evolut Pro device, a design based entirely on the Evolut R with the exception of the “skirt.”
Medtronic has worked for some time to make the basic Corevalve retrievable so operators can reposition the device, a boon for less experienced operators. This is a preliminary study, but there were no incidents of moderate or severe leakage at 30 days in any of the 60-some odd enrollees, a big improvement over 30-day data for the Evolut R. More than one in three of the devices used in this study were repositioned, and pacemaker rates were down sharply compared to Evolut R.
For the regulatory geeks in the crowd, the question here is whether the FDA sees this as a PMA supplement or a traditional PMA. There seems to be some thought that the FDA will decide on this device in the near term – before the end of the year, perhaps – which sounds like a PMA supplement because that is nowhere near enough time for a pivotal study. And before we dismiss this as non-news, let’s remember that Jeff Popma of Beth Israel Deaconess called out the FDA in a public forum two years ago (almost to the day, as a matter of fact) on the question of whether a pivotal clinical trial mandate is really justified for a modestly modified PMA device.
Popma had argued that 30-day data for Edwards Lifesciences’ Sapien 3 foreclosed the need for a new clinical trial, a position that might seem to be taking root at the FDA. The event in question? Why, ACC 2015, of course. Just look up the March 18, 2015, issue of Medical Device Daily to see for yourself.