Medtronic has revealed new long-term outcomes from its SPYRAL HTN-ON MED trial, demonstrating significant blood pressure reductions in patients treated with the Symplicity Spyral renal denervation (RDN) system.
The findings were presented at the 2024 Transcatheter Cardiovascular Therapeutics Conference.
SPYRAL HTN-ON MED is a global, randomised, sham-controlled study assessing the blood pressure-lowering effect and RDN safety using the radiofrequency-based Symplicity Spyral RDN system in hypertensive patients on up to three anti-hypertensive therapies.
The two-year data aligns with previous long-term results, showcasing meaningful and enduring blood pressure decreases.
Patients treated with RDN experienced a 24-hour ambulatory systolic blood pressure (ABPM) reduction of 12.1mmHg compared to a 7.0mmHg reduction in the sham group, resulting in a treatment difference of 5.7mmHg.
Office-based systolic blood pressure (OSBP) also saw greater declines, with a 17.4mmHg decrease in the RDN group versus a 9.0mmHg decrease in the sham group, marking an 8.7mmHg difference.
Following a six-month primary endpoint evaluation, researchers continued to monitor 24h ABPM and OSBP annually.
Medtronic has also announced plans for further investigation into multi-organ denervation using the Symplicity Spyral catheter.
The upcoming SPYRAL GEMINI pilot study will evaluate the efficacy and safety of denervating both the hepatic and renal arteries in patients with uncontrolled hypertension, regardless of their medication status. This approach remains investigational and is not yet approved for clinical use.
Additionally, Medtronic is expanding its GSR-DEFINE clinical trial to include sites in the US.
This observational study is an extension of the Global SYMPLICITY Registry and aims to enrol up to an additional 2,000 patients globally, building on data from 3,000 participants from the original GSR study.
Medtronic cardiovascular portfolio coronary and renal denervation business senior vice-president and president Jason Weidman said: “Medtronic is uniquely positioned to explore the blood pressure lowering potential of multi-organ denervation. This is supported by both its intellectual property and the Symplicity Spyral catheter design, which enables access and treatment of the common hepatic artery - a vascular target rich with sympathetic innervation - with the same single catheter.
"The promising preclinical data highlight the potential for interventional denervation in the liver to support additional blood pressure lowering effects of the procedure. This approach underscores our dedication to innovation for both patients and physicians.”
In November 2018, Medtronic received approval from the US Food and Drug Administration to study its Symplicity Spyral RDN system in a clinical trial for hypertension patients.
