FDA approves Medtronic renal denervation trial in on-med patients

Medtronic (NYSE:MDT) said today that the FDA approved a clinical trial of its Symplicity Spyral renal denervation device in patients who already take medication for their high blood pressure. Fridley, Minn.-based Medtronic said the three-year, 340-patient Spyral HTN-On Med sham-controlled study is designed to compare treatment with the Symplicity Spyral device and a sham procedure, randomized on a 2:1 basis, after treatment with up to three anti-hypertensive medications, including diuretics, calcium channel blockers, ACE/ARB inhibitors and beta blockers. The primary safety endpoints include major adverse events at one month and new renal artery stenosis at six months. The primary efficacy endpoint is 24-hour ambulatory blood pressure at six months. The pivotal trial is based on a pilot investigational device exemption study that showed an average 9mm Hg drop in 24-hour mean systolic ambulatory blood pressure in the treatment arm at six months. “Medtronic is committed to building a robust global renal denervation clinical program with results from several randomized, sham-controlled, prospectively-powered, blinded clinical studies, in both the absence and presence of prescribed medications,” coronary & renal denervation GM Dave Moeller said in prepared remarks. “Results from the On Med trial will add to the growing body of evidence supporting renal denervation and is intended to support clinicians in making treatment decisions for patients who might ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Featured Vascular Hypertension Medtronic Renal Source Type: news