Medtronic’s Symplicity Spyral to begin clinical trial

The FDA has given the go-ahead for the ON MED clinical trial to measure Medtronic’s Symplicity Spyral renal denervation system, a minimally invasive, radio frequency-based procedure that regulates nerve activity to and from the kidney. The trial will evaluate the system’s ability to treat uncontrolled hypertension, and involve around 340 patients across the world on high blood pressure medication who will be prescribed a stable regimen of up to three anti-hypertensive medications, including calcium channel blockers, diuretics, ACE/ARB inhibitors or beta blockers. The primary efficacy endpoint is 24-hour ambulatory blood pressure at six months. Primary safety endpoints will include major adverse events at one month and new renal artery stenosis at six months.
David Kandzari, M.D., director of interventional cardiology and chief scientific officer at Piedmont Heart Institute, said: “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. This trial will add yet another critical piece to the RDN evidence basis and is designed to build on the success of our pilot study, which showed a benefit for RDN in an on-med patient population.”