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Renal Denervation: Stepping Back To Move Forward

With the announcement that Medtronic is going back to the clinical drawing board after the pivotal SYMPLICITY HTN-3 trial of its renal denervation device failed to meet its primary efficacy endpoint, the industry is taking a cautious but still optimistic stance on the highly touted potential treatment for resistant hypertension.

Hypertension is the single largest contributor to death worldwide, increasing the risk of heart attack and stroke for more than 77 million Americans and about one billion adults worldwide. Approximately 10% of those diagnosed have severe resistant hypertension – defined as a systolic blood pressure of 140 mm Hg or higher despite adherence to at least three maximally tolerated doses of antihypertensive medications. With a lack of effective treatment options, the promise of a device-based therapy for resistant hypertension entered the picture about five years ago, on the heels of the successful use of catheter-delivered radiofrequency (RF) ablation for the treatment of complex ventricular arrhythmias, certain cancers, and other disorders. Early data from trials in which renal denervation (RDN) therapy was used to disrupt the renal nerves that regulate blood pressure demonstrated reductions of approximately 30 mm Hg at three-year follow-up. This is a tremendous result considering that each 2 mm Hg reduction in systolic blood pressure confers a 10% cardiovascular mortality reduction, according to studies. With these dramatic results, an exuberant industry flocked to the high-potential RDN space.

Catheter-based RDN is in clinical use in more than 80 countries, including parts of Europe, South America, Australia, and Canada....

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