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Medtronic Recall Raises Red Flag For Drug-Coated Balloons Below The Knee

This article was originally published in The Gray Sheet

Executive Summary

Drug-coated balloons have emerged as one of the next major product segments within interventional cardiology, particularly for the treatment of peripheral arterial disease. But a recent recall from Medtronic based on clinical trial data could temper enthusiasm for using the technology below the knee in patients with critical limb ischemia.

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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.

Renal Denervation Downer: Medtronic’s Pivotal Trial Misses Efficacy Endpoint

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.

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With a total market potential estimated in the multibillion-dollar range, the drug-coated balloon opportunity is attracting a growing list of competitors, including several leading multinational cardiovascular device companies that have entered the space via recent acquisitions. DCBs still need to prove their worth in large, long-term clinical trials, but the ultimate proving point for DCBs could center on cost: if they can offer an effective treatment option that is significantly less expensive than existing devices, DCBs may provide a compelling economic argument.

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