Medtronic has announced new positive long-term data from the SPYRAL HTN-ON MED trial of its Symplicity Spyral renal denervation (RDN) system.
SPYRAL HTN-ON MED is a global, randomised, sham-controlled trial that is examining the effects of blood pressure reduction and the safety of RDN.
The trial involves the use of the radiofrequency-based Symplicity Spyral RDN system in hypertensive patients on up to three anti-hypertensive medications.
Following the six-month primary endpoint assessment, the study evaluated 24-hour ambulatory systolic blood pressure (ABPM) and office-based systolic blood pressure (OSBP) from baseline through annual follow-ups.
Patients receiving radiofrequency renal denervation with the Symplicity Spyral system showed significant reductions in 24-hour ABPM and OSBP at two years.
The two-year data for Symplicity RDN aligns with previous long-term studies, showing clinically meaningful, consistent, and sustained blood pressure reductions.
The results indicated significant differences in 24-hour ABPM and OSBP favouring the RDN group, despite more medications in the sham group.
Additionally, long-term safety was demonstrated with no confirmed renal artery stenosis of more than 70% in the Spyral group at two years.
SPYRAL HTN-ON MED trial principal investigator David Kandzari said: “These findings are a key step toward informing the medical community of the long-term effectiveness with radiofrequency renal denervation as a treatment for uncontrolled hypertension.”
Medtronic plans to explore multi-organ denervation using the Symplicity Spyral catheter.
The upcoming global pilot study, known as SPYRAL GEMINI, will assess the safety and efficacy of this multi-organ ablation approach in patients with uncontrolled hypertension, both on and off medications.
The healthcare technology company also plans to expand the GSR-DEFINE clinical trial to US sites. This trial is an extension of the Global SYMPLICITY Registry and is a prospective, all-comer observational study involving 251 sites across 55 countries.
It includes 3,000 patients from the GSR study and aims to enrol up to an additional 2,000 patients globally.
Medtronic coronary and renal denervation business global marketing vice president and renal denervation general manager Jason Fontana said: “This year at TCT, we are not only reinforcing the consistent, long-term effects of radiofrequency denervation, but we’re further demonstrating our commitment to evidence generation and innovation.”
The Symplicity Spyral RDN system was approved by the US Food and Drug Administration (FDA) in November 2023.
The system is now approved for commercial use in over 75 countries. In May 2024, it received regulatory clearance in China.
