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Another Chance for Medtronic ’s Renal Denervation Therapy
Medtronic has yet another chance to prove its renal denervation therapy can treat uncontrolled hypertension. The Dublin-based company has received FDA approval to begin a clinical trial to evaluate the Symplicity Spyral renal denervation system with patients on medication for high blood pressure. The ON MED Trial is a 2:1 randomized, sham-controlled study and will randomize up to 340 patients at 55 centers in the U.S., Japan, Europe, Australia and Canada. Patients will be followed out to three years. Primary safety endpoints will include major adverse events at one month and new renal artery stenosis at six months. The pri...
Source: MDDI - November 8, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news