Medtronic’s hypertension device has been shown to be safe and effective at reducing office-based blood pressure in patients prescribed up to three medications.
Healthcare technology leader Medtronic, has announced six-month results from a clinical trial examining the effectiveness of its Symplicity Spyral Renal Denervation (RDN) System for reducing blood pressure.
The randomised, sham-controlled trial, known as SPYRAL HTN-ON MED, investigated the blood pressure lowering effect and safety of RDN with the radiofrequency (RF)-based Symplicity Spyral RDN system in hypertensive patients who have been prescribed up to three anti-hypertensive medications.
This includes diuretics, calcium channel blockers, ACE/ARB inhibitors or beta blockers.
A total of 337 patients with uncontrolled hypertension were enrolled at 42 sites across the United States, Europe, Japan, Australia and Canada.
Participants who were prescribed antihypertensive medications and treated with the device had a statistically significant reduction in office-based systolic blood pressure (OSBP), a key secondary endpoint, compared to subjects in the control group.
However, in the primary endpoint, RDN did not demonstrate a statistically significant reduction in 24-hour ambulatory systolic blood pressure (ABPM). This was due to increased medications in the control group and the potential impacts of the Covid-19 pandemic on the clinical trial environment.
The study also included Win Ratio, a pre-specified secondary endpoint that combines reduction in blood pressure with reduction in medication burden, which enables assessment of the overall beneficial effect of RDN.
The Win Ratio demonstrated significance in favour of RDN versus a sham procedure.
Finally, the study met its primary safety endpoint, with a low incidence of procedure-related and clinical adverse events.
Along with real-world data from the Global SYMPLICITY Registry (GSR), the Medtronic RDN program is backed by experience in more than 20,000 patients treated globally, studied in the presence and absence of medication and in patients with high baseline cardiovascular risk.
David Kandzari, MD, chief, Piedmont Heart Institute and Cardiovascular Services and SPYRAL HTN-ON MED lead principal investigator, commented: “The ON MED study demonstrated significant reductions in office-based blood pressure, the most commonly used measure in clinical practice. Additionally, we saw reductions in absolute blood pressure that were consistent with earlier RDN studies.
Surprisingly, 24-hour ABPM declined with RDN but did not differ from the sham group, and the primary endpoint was not met. More than 80% of patients in the ON MED expansion group experienced follow up during the Covid-19 pandemic. Compared with patients enrolled before the pandemic, significant differences in baseline 24-hour ABPM were observed that may reflect changes in patient behaviour and lifestyle during the pandemic.
“Additionally, patients treated with the sham procedure increased the amount of medication they were taking compared to those treated with RDN. These factors likely contributed to the smaller than expected differences in ABPM.”
Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business, which is part of the Cardiovascular Portfolio at Medtronic, added: “In addition to the consistent absolute blood pressure drops that we have demonstrated across trials, long-term data from key Medtronic studies— which were highlighted in two important publications this year in The Lancet — have also demonstrated the durability and ‘always on’ effect of RDN.
“The ON MED results presented today serve as an additional piece of our extensive compendium of safety and efficacy evidence on this procedure. With these results in hand, we submitted our PMA package to the FDA, which includes the totality of available evidence from the SPYRAL HTN clinical program. We are excited about the potential to bring this important procedure to millions of U.S. patients in need.”
The data was presented as Late-Breaking Clinical Science at the American Heart Association (AHA) Scientific Sessions 2022.
With this news, Medtronic has submitted the final module of the Symplicity Spyral™ Premarket Approval package to the US Food and Drug Administration (FDA) for approval.
