The Eluvia drug-eluting stent is made with laser-cut nitinol. [Image courtesy of Boston Scientific]
Boston Scientific recently shared new clinical data sets on the use of its Eluvia drug-eluting stent for treating peripheral artery disease (PAD). The studies — including a large-scale meta-analysis, two-year trial and real-world study — demonstrate Eluvia’s ability to outperform other stent technology and its reduction of major amputation risk and hospital readmission.
Following the April 23 release of the clinical data, Dr. Michael Jaff, chief medical officer and VP of Peripheral Interventions at Boston Scientific, sat down with Medical Design & Outsourcing for a wide-ranging conversation on the mounting data backing Eluvia and the future of this technology.
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Responses have been edited for length and clarity.
MDO: Eluvia has been FDA-approved since 2018. What kind of need is it filling when it comes to PAD?
Dr. Michael Jaff: Prior to Eluvia and the drug-coated balloons, surgical bypass was the mainstay for people with PAD of the legs, and no patient wanted bypass. It’s a big deal.
What Eluvia has been able to do is unlock results without having to do an open incision, go under anesthesia, etc. It’s been phenomenal. It got on the market because of the first ever randomized, head-to-head, prospective, multi-center trial compared to the market leader at the time.
Most of these devices, even today, only compare against balloon angioplasty, which is never going to do as well. But Boston Scientific took Eluvia and put it up against [Cook Medical’s] Zilver PTX, the only other device of its kind on the market. It was designed to show equivalence, but it actually showed superiority. It got published in a major journal.
Since then, the data continues to emerge, both data that we support and independent studies that are done by physicians, that Eluvia is just the most durable, best outcome, non-surgical device for the treatment of PAD of the leg.
MDO: How is the device able to deliver a superior outcome?
Dr. Michael Jaff, chief medical officer and VP of Peripheral Interventions at Boston Scientific [Image from Jaff’s LinkedIn profile]
MDO: Developing that and seeing how it worked out in the field, what kind of challenges did Boston Scientific have to overcome to get there?
MJ: I think the advantage is that the company has a long, deep internal history in R&D with drug-device combinations. This is what the company’s done since the coronary days. And so I think they took a lot of the engineering know-how and transferred it to a blood vessel that sorely needed a good solution. And, of course, you never know until you do the trial. But ever since IMPERIAL has been done, the data just continues to flow, showing outstanding results.
MDO: The data that recently came out and we reported on, what is that telling us that we didn’t know about Eluvia before?
MJ: I think there’s a couple of things. One, the meta-analysis took virtually any reasonably done study that’s been published in the peer-reviewed literature and statistically looked at. If you take all of those studies, put them together, do you still get the same outcomes as you see on these individual studies? That’s the power of a meta-analysis. And in fact, it did show outstanding results, as you guys reported.
Then, you have this real-world evidence data source; 111 million patient records in the United States are uploaded every night with every bit of detail that an electronic health record includes. And that also showed an incredibly meaningful outcome, one that sorely is needed. If you treat somebody with leg artery disease with Eluvia compared to bare devices, do you prevent limb loss? At the end of the day, that’s what patients are most worried about. ‘I don’t want to lose my leg.’
Eluvia prevented amputations more than any other implantable device in that real-world data source.
The independently run physician SPORTS trial, this was a trial like I’ve never seen in my career. Three different treatment arms, randomized head-to-head, one to one to one, where the primary endpoint was an angiogram, not an ultrasound, not a blood pressure cuff test but the most sophisticated measure of: How well does a device keep an artery open?
And that was a trial that looked at a drug-coated balloon, not a Boston Scientific product, but a drug-coated balloon that’s been on the market in Europe for a while, a bare stent and the Eluvia device.
And at one year, the Eluvia device was statistically better than either two therapies in preventing renarrowing based on that angiogram at 12 months.
But 12 months is one thing. What about when you go out longer? What was presented at this meeting in London was the two-year results. And the two-year results look as outstanding as the one-year results. Statistically superior at keeping the artery open longer on angiogram, the need for a repeat procedure dramatically, statistically lower if you use Eluvia than the drug-coated balloon or the bare stent. And so we continue to see this constant story.
MDO: These types of results, what does that mean for the future of this therapy? Is this going to drive home even more that this is the way to go when we have these types of cases?
MJ: That’s right. I think it gives physicians great confidence to know that when they’re faced with the toughest of the tough, there is an overwhelming body of literature that’s really modern. It says that Eluvia, as the first-line treatment, is the right thing to do. I think that’s the best part about this.
MDO: Where could Boston Scientific improve on this technology in the future?
MJ: First of all, I think we can make the devices longer and larger to treat other arteries that wouldn’t necessarily be well treated with Eluvia today. I think those are really exciting.
And then, of course, our know-how on drug device combination products opens up the door for many other avenues of investigation and R&D. I think we can all look forward to that as well.
MDO: There’s a lot of success with drug-eluting stents for peripheral problems. Could we figure out the challenges we’ve seen in the past with cardiac stents?
MJ: One thing I’ve learned in my career, taking care of a lot of patient,s is that it’s tempting to say, ‘If I can get it to work in one artery, it ought to work in every one.’ But just look at the main artery in the thigh and compare it to the main artery in the heart. You’re looking at an artery that’s a fifth of the length, a quarter of the diameter, with different flow characteristics. It’s just hard to compare the heart to the lower extremity arteries.
Obviously, Boston Scientific got the Agent drug-coated balloon approved for coronary in-stent restenosis. I do think that more investigations are leading to more knowledge about what can work in the heart arteries with drug-coated balloons and other drug-device combinations. I think the future is very bright.
Chris Newmarker is editor in chief of MassDevice and Medical Design & Outsourcing. Carrie Pallardy is a freelance writer and editor based in Chicago. She has more than a decade of experience writing and reporting in the healthcare space.
