As part of the medtech giant’s Spyral HTN global clinical program, three-year data from the Spyral HTN-ON MED and GSR-Define trials were presented at EuroPCR 2022 as late-breaking clinical trials demonstrating the benefit of the Symplicity blood pressure procedure with Simplicity Spyral.
The Medtronic RDN minimally invasive procedure delivers radiofrequency energy to specific nerves near the kidneys that can become overactive and cause high blood pressure. It is currently limited to investigational use in the United States, Japan and Canada.
Results from the first 80 patients in the Spyral HTN-ON MED trial show improved blood pressure control with significantly higher time in target range (TTR) after radiofrequency RDN when compared to sham through three years, regardless of anti-hypertensive medications.
TTR for patients treated with RDN registered at 33.7%, nearly doubling (18.8%) the outcome for sham patients through three years, according to a news release.
In the GSR-Define study, it was observed that improved blood pressure control after radiofrequency RDN is associated with a lower risk of major adverse cardiovascular events (MACE) through three years, with RDN patients spending 34.9% of the time in TTR over three years and a 16% drop in MACE associated with every 10% increase in TTR at six months.
The GSR-Define trial covered 3,000 patients from the GSR study and is enrolling up to an additional 2,000 patients across 222 sites in 42 countries.
“The data presented today at EuroPCR provide meaningful insights into the benefits of RDN through a patient lens, looking at how much time they spend within a target BP range,” Medtronic SVP and President of the Coronary and Renal Denervation Business Jason Weidman said in the release. “This new data reinforces RDN’s effectiveness as a complementary solution for achieving better blood pressure control and reducing cardiovascular risk.”
In October 2021, Medtronic announced that the Spyral HTN-ON MED study of Symplicity Spyral would continue into 2022 after lacking the positive results needed to end enrollment early. Despite that setback, company officials remain confident that renal denervation is still a multi-billion dollar market opportunity. CEO Geoff Martha said in January that Medtronic expects follow-up with completion in the second half of this calendar year, followed by submitting data to the FDA for approval.