Studies Support Medtronic's Renal Denervation System in High-Risk Hypertensive Patients
May 22, 2019—Medtronic announced that late-breaking clinical data from a physician-sponsored clinical trial using the company's Symplicity renal denervation (RDN) system were presented at EuroPCR held May 21–24 in Paris, France.
According to the company, the results from the single-center, randomized, sham-controlled study indicate that RDN with the Symplicity system was associated with reduced occurrence of subclinical atrial fibrillation (AF) in a small subset of high-risk patients with hypertensive heart disease over a median follow-up period of > 2 years.
The Medtronic-funded, investigator-led study randomized 80 patients to either RDN with the Symplicity system or a sham procedure. The results from the study demonstrate that subclinical AF developed at a lower rate in the group of patients who received RDN than in patients who received the sham procedure (19% vs 47%, respectively). AF occurrence was monitored by Medtronic's implantable diagnostic technology.
The study's Principal Investigator, Marshall J. Heradien, MD, commented in Medtronic's announcement, "In this high-risk cohort of patients with hypertensive heart disease who are at risk for AF and cardiovascular death, this study suggests there may be an important benefit provided by renal denervation. Consistent with previous studies, these data show that the RDN procedure offers a lasting, positive effect that may translate into improved clinical outcomes." Dr. Heradien is a cardiologist and specialist physician at Stellenbosch University in Cape Town, South Africa.
Also at EuroPCR, investigators reported new 3-year data from the global Symplicity registry, which is the largest registry documenting the long-term safety and effectiveness of the Simplicity RDN system in a real-world setting in patients with uncontrolled hypertension. To date, the registry has enrolled more than 2,600 patients treated with RDN and includes 3-year follow-up for more than 2,300 patients.
According to Medtronic, the latest outcomes from the registry showed that RDN led to significant and clinically meaningful reductions in both office and ambulatory blood pressure, which were sustained out to 3 years postprocedure (16.5 mm Hg office systolic blood pressure and 8.9 mm Hg 24-hour systolic ambulatory blood pressure monitoring).
The registry findings showed that blood pressure reductions were consistent and sustained across various high-risk patient subgroups, including patients with diabetes, isolated systolic hypertension, chronic kidney disease, and resistant hypertension, as well as patients aged 65 years or older.
Approved for commercial use in more than 50 countries around the world, the Symplicity Spyral system is limited to investigational use in the United States, Japan, and Canada, advised Medtronic.