Minnesota medtech giant Medtronic (NYSE:MDT) announced today that it began enrolling the 1st patients in the SYMPLICITY HTN-4 hypertension trial, the 1st renal denervation study of its kind with both blinding and a control arm to examine renal denervation therapy in patients with moderate uncontrolled hypertension.
The study is significant not only as a test of Medtronic’s Symplicity renal denervation system, but as a milestone for renal denervation therapy in general, poised to provide some of the most robust data yet on the technology in treatment of hypertension in less severe patients.
"SYMPLICITY HTN-4 demonstrates Medtronic’s commitment to providing randomized safety and efficacy data for renal denervation in a wide variety of patients, as well as helping increase our understanding of the potential benefit of renal denervation for more patients with treatment resistant hypertension," Medtronic renal denervation general manager and vice president Nina Goodheart said in prepared remarks.
The trial includes about 100 clinical sites where doctors will enroll up to 580 patients with systolic blood pressure between 140 and 160 mm Hg. Along with SYMPLICITY HTN-3, the HTN-4 study is expected to provide what may be the most robust and reliable findings to date on renal denervation in managing uncontrolled hypertension.
HTN-4 is part of Medtronic’s larger clinical program for its renal denervation technologies, starting with the HTN-1 pilot studies, now the longest-running renal denervation safety and efficacy trials, and including global registries, heart failure studies and regional trials in Japan and India.
Medtronic’s Symplicity system is already on the market in 80 countries, with more than 5 years of clinical experience. The device in 2008 won CE Mark approval in the European Union and has notched a series of regulatory wins over the years, including Australian and European approvals earlier this month for next-generation components of the platform.
Medtronic is a front-runner in the race to bring renal denervation technology to the U.S., although the field has lost some of its shine. The technology, once a darling of medical device conferences and industry headlines, has slipped from the spotlight over the last year as the market proved less lively than previously expected. Some reports issued during this year’s TCT conference may have helped rejuvenate interest in the procedure, which researchers have suggested may have applications in ailments ranging from chronic kidney disease to diabetes and obstructive sleep apnea.