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Cardiovascular Devices For Hypertension: FDA Outlines Clinical Trial Tips

This article was originally published in The Gray Sheet

Executive Summary

FDA offers advice for designing clinical trials of cardiovascular devices to treat drug-resistant hypertension, as several major players look to stake a claim in the space.

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With the recent success of Ardian’s Symplicity Renal Denervation System, drug-resistant hypertension has emerged as something of a device market “gold rush.” Some observers estimate there are now as many as 40 companies developing various device-based therapies for resistant hypertension, including most of the big names in the cardiovascular device arena – Medtronic, St. Jude Medical, Boston Scientific, Johnson & Johnson, and Covidien PLC – along with a number of start-ups, all of which are racing to stake a claim in this highly promising market. Only time will tell which companies will be successful – even Medtronic, the first player, has yet to complete its sham-controlled US trial. But the technology’s early promise, along with the sheer size of the opportunity and the acute unmet need, clearly have peaked the interest of investors, manufacturers, and physicians alike, all of whom are chasing after what one participant has called “the next biggest thing in cardiology.”

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Potential growth drivers identified by the firm during its April 19 first-quarter earnings call include the Ingenio family of pacemakers and BSX-manufactured Promus Element everolimus-eluting stent system.

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