As part of the firm’s SPYRAL HTN Global Clinical Programme, the three-year data from SPYRAL HTN-ON MED and GSR-DEFINE studies were presented as late-breaking clinical trials at EuroPCR 2022
The world headquarters of Medtronic is located in Fridley, Minnesota, USA. (Credit: Bobak Ha'Eri/Wikipedia)
Medtronic announced that the data revealed the benefits of using the Symplicity Spyral Renal Denervation (RDN) system for Symplicity Blood Pressure procedures.
The data demonstrated that the system achieved target blood pressure level ranges with more time in the target range.
As part of the firm’s SPYRAL HTN Global Clinical Programme, the three-year data from SPYRAL HTN-ON MED and GSR-DEFINE studies were presented as late-breaking clinical trials at EuroPCR 2022.
The Medtronic RDN system involves delivering radiofrequency radiation to certain nerves near the kidneys that can become hyperactive and produce high blood pressure.
SPYRAL HTN-ON MED is a global, randomised, sham-controlled trial investigating the blood pressure-lowering effect and safety of RDN. It recruited 80 typical uncontrolled hypertensive patients, randomised to RDN.
All 80 patients in the study showed improved BP control and a significantly higher time in target range (TTR) after radiofrequency RDN over three years as compared to sham, regardless of anti-hypertensive drugs.
GSR-DEFINE is an observational study in 222 sites across 42 nations, including 3,000 patients from the GSR study and recruiting up to an additional 2,000 patients.
The study showed improved blood pressure control after radiofrequency RDN was linked to a lower risk of major adverse cardiovascular events (MACE) in real-world patients over three years.
RDN patients spent 34.9% time in TTR through three years. There was also a 16% drop in MACE related to every 10% increase in TTR at six months.
Medtronic Coronary & Renal Denervation business president Jason Weidman said: “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.
“This new data reinforces RDN’s effectiveness as a complementary solution for achieving better blood pressure control and reducing cardiovascular risk.”
The Symplicity Spyral renal denervation system is approved for commercial use in more than 60 countries across the world, but it is only available for investigational use in the US, Japan, and Canada.