Firms Tout Data On Next-Gen Stents, But FDA Hurdles May Be Steep
This article was originally published in The Gray Sheet
At major cardio meetings this month, stent makers – both start-ups and traditional market leaders – showcased promising data on several next-gen drug-eluting stent systems intended to improve safety, but cardiologists worry that FDA requirements may be too steep.
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The firm characterizes the early-stage technology as its answer to Abbott’s bioabsorbable vascular scaffold and Boston Scientific’s bioabsorbable polymer coronary stents.
Recent debuts include NuVasive’s PCM cervical disk system, Boston Scientific’s bioabsorbable Synergy drug-eluting stent in Europe and Medtronic’s MRI-safe Advisa pacemaker in Japan.