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 primary efficacy endpoint is 24-hour ambulatory blood pressure at six months. Subjects will be prescribed a stable regimen of up to three anti-hypertensive medications, including diuretics, calcium channel blockers, ACE/ARB inhibitors or beta blockers. "A broad range of patients suffer with hypertension today, many of whom remain uncontrolled despite being prescribed a variety of medications; the consequences of uncontrolled hypertension represent both a substantial impact to public health and a large unmet need in medicine for new approaches," David Kandzari, M.D., director of interventional cardiology and chief scientific officer at Piedmont Heart Institute, principal investigator and member of the SPYRAL HTN Global Clinical Program Executive Committee, said in a release. "This trial will add yet another critical piece to the RDN evidence basis and is designe...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news