Boston Scientific (NYSE:BSX), stung by recent studies showing that the thinner design of next-generation stents can deform during deployment, is on the offensive with an new video.
At least two studies and one case study presented last year at the Transcatheter Cardiovascular Therapies conference in San Francisco reported incidents in which stents made by Boston Scientific and its main competitors, Abbott (NYSE:ABT) and Medtronic (NYSE:MDT), deformed after they were deployed inside coronary arteries.
The FDA has taken an interest in the concerns, launching an investigation into newer stent models. BSX came up with new labeling language for its Promus Element stent to detail how the stent might deform, spokeswoman Denise Kaigler told MassDevice last December.
The Boston Scientific video, "Beyond the hype: A closer look at the manifestation and clinical impact," stresses that longitudinal stent deformation is a rarity that can occur with any of the newer stent platforms, including its own platinum-chromium line and competing devices from Abbott (NYSE:ABT) and Medtronic (NYSE:MDT).
"Stent deformation is an extremely rare event and is difficult to re-create," according to the video. "Although a rare phenomenon, today’s thin-strut stents are all susceptible to longitudinal stent deformation."
That includes the BSX Ion/Taxus stent, Abbott’s Xience platform and the Endeavor line from Medtronic, according to the video, which also notes that the forces applied by a catheter during percutaneous coronary interventions are more than sufficient to deform any stent.
"Post-dilation catheter tip supplies ample force to compress," it states. "Significant forces can be generated using normal procedural techniques."