Firms Tout Data On Next-Gen Stents, But FDA Hurdles May Be Steep

21 Nov 2011

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.

The latest generation of cardiovascular stents could dramatically improve on current drug-eluting stent platforms – with better safety profiles and improved healing – but the barriers to entry at FDA could prevent these products from seeing the light of day, some cardiologists warn.

At major cardio meetings this month, stent makers, both start-ups and traditional market leaders, showcased data on several next-gen systems...