Boston Scientific (Natick, MA) isn't exactly shrinking from recent criticism regarding instances of longitudinal stent deformation in its thin-strut Ion paclitaxel-eluting platinum-chromium (PtCr) coronary stent system. Instead, the medical device giant has posted an informative—though unlisted—video on YouTube titled, "Beyond the Hype: Longitudinal Stent Deformation," which emphasizes the rarity of longitudinal compression as well as the fact that all thin-strut drug-eluting stents are susceptible to the design flaw. But can the Ion restore its reputation?
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| The Ion PtCr thin-strut DES from Boston Scientific drew fire for its observed vulnerability to longitudinal compression. |
Longitudinal compression proved to be among the most-talked about topics in stent design this past fall, quickly escalating from a discussion in a case series in the medical journal EuroIntervention to the subject of several last-minute conferences at TCT and intense scrutiny. Several companies' thin-strut stent platforms were initially identified in the case studies as having demonstrated this type of stent deformation, including Biosensors International's biolimus-eluting BioMatrix stent, Boston Scientific's everolimus-eluting Promus Element stent, and Medtronic's zotarolimus-eluting Endeavor stent.
But Boston Scientific was dealt a further blow in November when Cindy Grines, a cardiologist and editor of the Journal of Interventional Cardiology, singled out the company's Ion stent as an especially worrisome offender. In addition to an article attributing a heart attack directly to the deformation of an Ion stent, Grines wrote an editorial in which she described the product's shrinkage as "disturbing." The Ion stent, according to Grines, exhibited deformation, accordioning, and shortening of approximately 35%.
Since the initial frenzy, the issue of longitudinal compression seems to have lost some steam as experts at TCT and elsewhere have attempted to slow the runaway panic train. As I noted in a recent editorial: "While presenters at TCT relayed anecdotes of longitudinal compression in various stents, most downplayed the issue as relatively rare and cautioned against getting caught up in the hype. Several speakers also noted that stent design may not be the sole culprit—surgical technique may also be a factor."
While surgical technique may be a factor in longitudinal compression, the flaw is still primarily chalked up to stent design as medical device companies strive to achieve products with ever-thinner struts. And that could pose a significant problem for the Ion and, to a lesser degree, the Promus Element stents moving forward.
With this in mind, Boston Scientific quietly posted a short video on YouTube earlier this month in a subtle form of damage control. "Although [longitudinal compression is] a rare phenomenon, today's thin-strut stents are all susceptible to longitudinal stent deformation," the video notes. This angle from the company is a smart one. Although Abbott would be quick to refute this claim, noting that its Xience stent has had "virtually no reports" of such stent deformation, other brands have experienced longitudinal compression. So, it makes sense to try and deflect—or at least share—the negative attention. There's definitely enough to go around, after all.
And of course there's the spin. "Improved radiopacity with the PtCr platform allows for better identification of longitudinal stent deformation compared to other, less-visible stents," the video states. "Improved identification allows a physician to respond if it occurs."
In the wake of the longitudinal compression hysteria, it's a prudent move by Boston Scientific to reassure customers and patients that longitudinal deformation is rare and is not unique to the company's PtCr platforms. But the video prompts several questions: What impact, if any, will the longitudinal compression debate have on Boston Sci's PtCr stents? Will the company's stents' reputation (and sales) suffer? And, perhaps most importantly: Will the company reevaluate the geometric design of its stents for next-generation products? It will be interesting to see how this all pans out.
Do you think the issue of longitudinal compression being brought to light will impact Boston Sci or any other thin-strut stent manufacturers? Can you see "beyond the hype?" Let us know in the comments section below. Also, check out Boston Sci's video and bone up on longitudinal compression in recent pieces from MPMN's archives, "Design Flaw Poses Potential Threat to Shrinking Drug-Eluting Stents" and "The Skinny on Thin-Strut Stents." --Shana Leonard
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