CONTEXT: Report of data presented at the EuroPCR annual meeting on Medtronic’s Symplicity Renal Denervation system. Results from a registry involving nearly 3,000 patients showed significant and clinically meaningful reductions in blood pressure that were sustained up to 3 years post procedure.
IMPACT: Medium
READ TIME: 2 mins
Quality Level Mean [1 – 10]: 7
1. “Medtronic Expands RDN Real-World Data Collection with the New GSR-DEFINE Study . Building on the success of GSR and continuing its commitment to providing real-world evidence for the Symplicity Spyral Renal Denervation System, Medtronic also announced today launch of the GSR-DEFINE Study.”
2. “Medtronic Launches New GSR-DEFINE Study to Expand Real-World Data to 5,000 Patients. DUBLIN, May 18, 2021 /PRNewswire/ — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced new clinical data from the Global SYMPLICITY Registry (GSR) indicating that renal denervation (RDN) with the Medtronic Symplicity™ Renal Denervation System was associated with clinically significant and sustained blood pressure reductions in a real-world hypertensive patient population through three years.”
3. “The similar clinical composite endpoint was used in a recent EuroIntervention publication that showed patients were nearly three times more likely to benefit from RDN compared to remaining on a regime of anti-hypertensive medications alone (Win Ratio = 2.78, p<0.001).1. “As we continue to expand our clinical data around renal denervation for uncontrolled hypertension management, we wanted to broaden our understanding of the long-term benefits for our patients who suffer from multiple chronic conditions and are typically prescribed multiple medications,” said Felix Mahfoud, M.D., cardiologist at Saarland University Hospital in Homburg, Germany and principal investigator in the study.”
4. “”Medtronic’s commitment to creating a minimally invasive solution to treat patients with uncontrolled high blood pressure is evident through our growing body of clinical evidence as part of our Symplicity Global Clinical Program,” said Jason Weidman, senior vice president and president of the Coronary & Renal Denervation business unit, which is part of the Cardiovascular Portfolio at Medtronic.”
5. “Along with the GSR and GSR-DEFINE studies, the Medtronic Symplicity Global Clinical Program also includes the SPYRAL HTN-OFF MED PIVOTAL and SPYRAL HTN-ON MED trials, both prospectively powered, randomized, sham-controlled studies evaluating patients with uncontrolled blood pressure in the absence and presence of prescribed anti-hypertensive medications respectively.2. Approved for commercial use in more than 60 countries around the world, the Symplicity Spyral Renal Denervation System is limited to investigational use in the U.S., Japan and Canada.”