FDA Approves SPYRAL HTN-ON MED Study of Medtronic's Symplicity Spyral RDN System
November 8, 2018—Medtronic announced FDA approval to begin a clinical trial to evaluate the company's Symplicity Spyral renal denervation (RDN) system in patients with uncontrolled blood pressure taking multiple antihypertensive medications. The SPYRAL HTN-ON MED trial is a prospectively powered, randomized, sham-controlled study within the broader Medtronic SPYRAL HTN global clinical program.
David Kandzari, MD, serves as the study's Principal Investigator and is a member of the Executive Committee for the SPYRAL HTN global clinical program. In Medtronic's announcement, Dr. Kandzari commented, "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." Dr. Kandzari is Director of Interventional Cardiology and Chief Scientific Officer at Piedmont Heart Institute in Atlanta, Georgia.
The ON MED trial is a 2:1 randomized, sham-controlled study that will enroll up to 340 patients at 55 centers in the United States, Japan, Europe, Australia, and Canada. Patients will be followed out to 3 years.
The study's primary safety endpoints will include major adverse events at 1 month and new renal artery stenosis at 6 months. The primary efficacy endpoint is 24-hour ambulatory blood pressure at 6 months. Patients will be prescribed a stable regimen of up to three antihypertensive medications, including diuretics, calcium channel blockers, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, or β-blockers.
Medtronic noted that the design of the ON MED trial builds on the randomized sham-controlled SPYRAL HTN-ON MED pilot study that was published earlier this year by Dr. Kandzari et al in The Lancet (2018;391:2346–2355). The 80-patient pilot study demonstrated statistically significant and clinically relevant reductions in both office and 24-hour systolic blood pressure. The blood pressure–lowering effects were observed not only throughout the daytime, but also during the nighttime and early morning periods when heart attack and stroke risk caused by hypertension are highest, resulting in the observation that RDN is "always on," stated the company.
The Symplicity Spyral system is limited to investigational use in the United States, Japan, and Canada. The device is approved for commercial use in more than 50 countries.