SYMPLICITY Results Make Life Difficult For Renal Denervation Programs
The big slice of the device industry, from large-cap firms to venture capitalists, with some stake in the renal denervation opportunity are trying to understand the new reality now that Medtronic’s pivotal Symplicity renal denervation device trial missed its endpoint.
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Manufacturers are finding it harder to innovate in the vascular interventional device arena as market and regulatory pressures take their toll. New coronary drug-eluting stents face a difficult challenge with the high bar now set by existing devices, and there have been several recent disappointments in the areas of renal denervation, drug-coated balloons, and renal artery stenting; still there are areas of opportunity that continue to look promising, with bioresorbable stents offering perhaps the best prospect among vascular therapies for future blockbuster status.
A Covidien executive said in an interview that the firm’s decision to halt development of its OneShot renal denervation system was made prior to Medtronic’s recent announcement that its Symplicity device missed its endpoint. Covidien cites slower-than-expected development of the renal denervation market.
The firm’s SYMPLICITY HTN-3 trial failed to meet its primary efficacy endpoint, scuttling Medtronic’s plans to earn a PMA for renal denervation this year. The primary investigator for the trial acknowledges in an interview that the finding raises serious questions for the future of renal denervation in hypertension.