At the Cardiovascular Research Technologies (CRT) 2025 conference in Washington, D.C., Medtronic presented new data and clinical milestones across its Coronary, Structural Heart and Renal Denervation businesses. The conference will showcase key data presentations and advancements across its Coronary, Structural Heart and Renal Denervation businesses in the Medtronic Cardiovascular portfolio. Additionally, Geoff Martha, chief executive officer and chairman at Medtronic, also provided the industry keynote, addressing the company's commitment to advancing cardiovascular care.
Medtronic Coronary continues to gain additional evidence for Prevail coronary paclitaxel drug-coated balloon (DCB). At CRT, Dr. Sacharias von Koch presented "Real-World Usage of Prevail Paclitaxel-Coated Balloon Compared with Other Contemporary Drug-Coated Balloons" This is a two-year analysis from the Swedish Coronary Angiography and Angioplasty (SCAAR) Registry in more than 6,000 patients.
The analysis of data from SCAAR on the Prevail coronary paclitaxel drug-coated balloon (DCB) will be presented as a late-breaking clinical trial at Cardiovascular Research Technologies (CRT) 2025 in Washington, D.C. The real-world patient population analysis, which is the largest dataset of Prevail patients with nearly 1,800 patients, compared the Prevail DCB to other DCBs in a complex patient population, including bifurcations, acute coronary syndrome and diabetes. Prevail DCB is limited to investigational use in the U.S. and Japan.
Among Medtronic's Structural Heart and Aortic key data milestones, Dr. Howard C. Herrmann presented "SMART 2-Year Data Update." The presentation addressed the two-year results of the SMall Annuli Randomized To Evolut or SAPIEN Trial, which evaluated a valve performance in individuals with aortic stenosis with small aortic annulus in patients treated with either Evolut TAVR platform or SAPIEN platform.
Yasser Sammour, MD, MSc presented "Long-Term Hemodynamic Performance and Clinical Outcomes in Small and Large Aortic Annuli Patients with Severe Aortic Stenosis." This study is a pooled analysis from the U.S. High Risk Pivotal and SURTAVI randomized controlled trials (RCTs), and the non-RCT US Extreme Risk trial and CoreValve Continued Access Studies assessed valve performance using 5-year bioprosthetic valve dysfunction (BVD). The association of BVD with clinical outcomes (unadjusted for covariates) was evaluated by small and large annuli (CT annular diameter ≤23 vs >23 mm).
Dr. Joachim Weil presented "Radiofrequency Renal Denervation Improves Cardiac Energetics." Weil is director of the Heart and Vascular Center, Sana Kliniken Lübeck. This presentation covered a three-month analysis from the previously-published SPYRAL HTN-OFF MED trial. It assessed Rate Pressure Product (RPP) — a measure of cardiac workload linked to long-term cardiovascular outcomes.
Weil also presented "Blood Pressure Reductions After Radiofrequency Renal Denervation By Patient Age Based On Medicare Eligibility" This moderated abstract presentation featured a pooled analysis from the SPYRAL HTN-ON and OFF MED studies assessing blood pressure changes in 388 RDN patients stratified by Medicare-eligible age: those under 65 years and those 65 years and older, over a period of two years.
”These data, which are consistent with real-world data published from GSR-DEFINE, provide further insights into patient selection for this procedure, demonstrating the consistency of the Symplicity blood pressure procedure in the management of uncontrolled hypertension, irrespective of patients’ age,” said Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business within the Medtronic Cardiovascular Portfolio.
"Blood Pressure Response Following Radiofrequency Renal Denervation" was presented by Dr. Jeremy Bock, Medical Director for Cardiology, and Interventional Cardiologist and Endovascular Specialist at VHC Health Physicians. Dr. Bock’s moderated abstract presentation addressed real-world data for Symplicity Spyral. The data included a study of the largest cohort of commercially treated, uncontrolled hypertensive patients at a single center (six months after approval) who underwent RF RDN with Symplicity Spyral. The analysis was conducted to assess blood pressure changes, specifically OSBP, at six- and twelve-months post-procedure. Safety outcomes, including the presence of renal artery stenosis greater than 70%, were also evaluated.
In addition to these presentations, the company plans to announce a critical milestone in its real-world study, GSR-DEFINE. The GSR-DEFINE trial is an extension of the Global SYMPLICITY Registry, and is a prospective, all-comer observational study in 251 sites across 55 countries, including a 5,000-patient cohort. To date, the trial has reached 4,000 patients enrolled.
Medtronic presented "robust data reinforcing the consistent, long-term efficacy of radiofrequency denervation. Additionally, with over 4,000 patients enrolled in the GSR-DEFINE clinical trial, we [are demonstrating] our ongoing commitment to evidence generation," said Jason Fontana, PhD, general manager Renal Denervation and vice president of Global Marketing for the Coronary and Renal Denervation business. "The Symplicity Spyral RDN system is extensively studied and has robust evidence to support clinical practice. We remain dedicated to furthering our investment in data to establish interventional hypertension procedures."
Other Medtronic leadership panel discussions at CRT included:
- Medtech town hall — a panel discussion with Nina Goodheart
- Renal Denervation: The Next Big Thing in Interventional Cardiology? — a panel discussion with Jason Fontana
- Medtech Keynote Address with Geoff Martha, Chairman and CEO of Medtronic.
For more information on Medtronic and its its Coronary, Structural Heart and Renal Denervation businesses, please visit www.Medtronic.com
January 27, 2025 
