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The Next Stent Frontier: Nanotechnology

This article was originally published in Start Up

Executive Summary

The medical device world is buzzing these days in anticipation of the early clinical success of drug-eluting stents in preventing restenosis, but it's never too soon to look toward the next generation of innovation. One of the next big steps on the stent horizon will be nanotechnology, according to interventional cardiologist Steven Bailey, MD.

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Is the FDA Ready for the Nanotechnology Revolution?

The burgeoning field of nanotechnology is creating hope as well as anxiety in the healthcare industry as researchers look for the best way to use the technology and the FDA grapples to create a policy for regulating products that incorporate the futuristic micro-miniature science. In health care, early focus has been on infection control products.

World Congress of Cardiology: DES Safety Dominates Discussions

While the greater efficacy of drug-eluting stents (DES) compared to bare-metal stents is widely accepted, over the past year, data has continued to build showing that first-generation DES also have a higher late-stage in-stent thrombosis risk, a complication that can cause death 30% of the time, according to some estimates. The findings of these studies had some physicians at this year's World Congress of Cardiology calling for "an immediate halt to DES overuse." However, most conceded that additional randomized trials will be needed to fully understand the potential risks associated with these devices.

In Two Recent Trials, Devices Trump Rx

Results of two recent studies reported at this year's American Heart Association meeting favor devices over therapeutics in treating certain cardiovascular conditions. The PRESTO trial results were the equivalent of a dodged bullet for stent companies; it showed no benefit from the drug Tranilast, a result which leaves intact the supposition that drug-eluting stents are the best restenosis treatment. And another major trial found that implantable LVADs have superior results in treatment patients with chronic end-stage heart failure.

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