Medtronic’s Symplicity Spyral RDN System Evaluated for Time-to-Target Range in SPYRAL HTN-ON MED and GSR-DEFINE

May 17, 2022—Medtronic announced data showing the benefits of the Symplicity blood pressure (BP) procedure with the company’s Symplicity Spyral renal denervation (RDN) system on achieving target BP level ranges. The 3-year data from the SPYRAL HTN-ON MED and GSR-DEFINE studies were presented as late-breaking clinical trials at the EuroPCR 2022 conference held May 17-20 in Paris, France.

SPYRAL HTN-ON MED and GSR-DEFINE are part of Medtronic’s SPYRAL HTN global clinical program. The Symplicity Spyral RDN system is approved for commercial use in more than 60 countries. It is limited to investigational use in the United States, Japan, and Canada, noted Medtronic.

According to the company, SPYRAL HTN-ON MED is a global, randomized, sham-controlled trial investigating the BP lowering effect and safety of RDN with Medtronic’s radiofrequency-based Symplicity Spyral system in hypertensive patients prescribed one to three antihypertensive medications. The trial enrolled 80 typical uncontrolled hypertensive patients, randomized to RDN (n = 38) or sham control (n = 42).

Medtronic reported that the results from the first 80 patients in the SPYRAL HTN-ON MED trial demonstrate improved BP control with significantly higher time-in-target range (TTR) after radiofrequency RDN when compared to a sham control through 3 years, regardless of antihypertensive medications. TTR was approximately double for patients treated with RDN versus patients treated with the sham control through 3 years (33.7% vs 18.8%; P = .023).

The company noted that the findings build on the recent 3-year safety and efficiency data demonstrating safe and sustained BP reductions through 3 years. Those data were presented during a featured clinical research session at ACC.22, the American College of Cardiology’s 71st annual scientific session held April 2-4 in Washington, DC.

In Medtronic’s press release from EuroPCR, SPYRAL HTN-ON MED lead Principal Investigator David Kandzari, MD, commented, “By focusing on TTR in patients with uncontrolled hypertension, we can better understand how RDN can help control BP and sustain a healthy level. These 3-year data showed us that RDN nearly doubles the time patients spend in their target BP range, regardless of antihypertensive medications, reinforcing the long-term benefit of the procedure.” Dr. Kandzari is chief, Piedmont Heart Institute and Cardiovascular Services in Atlanta, Georgia.

GSR-DEFINE is a prospective, all-comer observational study at 222 sites in 42 countries that includes 3,000 patients from the Global SYMPLICITY Registry study and enrolling up to an additional 2,000 patients.

In the GSR-DEFINE study, improved BP control after radiofrequency RDN is associated with lower risk of major adverse cardiovascular events (MACE) through 3 years in real-world patients. RDN patients spent 34.9% time in TTR through 3 years and had a 16% decrease in MACE associated with every 10% increase in TTR at 6 months.

Professor Felix Mahfoud, MD, Cardiologist at Saarland University Hospital in Homburg, Germany, and a member of the SPYRAL HTN executive committee, commented in Medtronic's press release, “Results from this real-world patient setting closely mirror and build upon data from the SPYRAL HTN-ON MED trial showing improved BP control with RDN. The findings from GSR-DEFINE further underscore the long-term safety and effectiveness of the Symplicity system in patients with uncontrolled hypertension, while also lowering their risk of major cardiovascular events.”