Renal Artery Stenosis

Company commits to advancing clinical data for Symplicity™ with the SPYRAL Gemini clinical trial and expansion of the GSR-DEFINE clinical trial GALWAY, Ireland and WASHINGTON, Oct. 28, 2024 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced new, long-term data from its SPYRAL HTN-ON MED clinical trial that showed subjects who underwent radiofrequency renal denervation with the Symplicity™ Spyral renal denervation (RDN) system had significantly greater reductions in 24-hr ambulatory systolic blood pressure (ABPM), and office-based systolic blood pressure (OSBP) compared to sham patients at two years. The data were presented as a part of the 2024 Transcatheter Cardiovascular Therapeutics Conference (TCT). "These findings are a key step toward informing the medical community of the long-term effectiveness with radiofrequency renal denervation as a treatment for uncontrolled hypertension," stated Dr. David Kandzari, Chief of Piedmont Heart Institute and Cardiovascular Services and lead principal investigator of the SPYRAL HTN-ON MED trial. "Importantly, at two years, we continue to see Symplicity is safe and consistent with clinically meaningful and significant blood pressure reductions. These data further substantiate sustained blood pressure reductions consistently observed in across the SPYRAL and Global Symplicity clinical programs." The two-year data is consistent with other long-term data for Symplicity RDN, demonstrating clinically meaningful, consistent and sustained blood pressure reductions.1,2 At two years, the data showed: Significant group differences in 24-hr ABPM and OSBP in favor of RDN, despite significantly more medications detected in the sham group 24 months ABPM: -12.1 mmHg in RDN group vs. -7.0 mmHg in sham group (treatment difference: -5.7 mmHg; p=0.039) OSBP: -17.4 mmHg in the RDN group vs. -9.0 mmHg in the sham group (treatment difference: -8.7 mmHg; p=0.0034) Long-term safety with no confirmed renal artery stenosis greater than 70% in the Spyral group at two years SPYRAL HTN-ON MED is a global, randomized, sham-controlled trial investigating the blood pressure lowering effect and safety of RDN with the radiofrequency-based Symplicity Spyral RDN system in hypertensive patients who have been prescribed up to three anti-hypertensive medications. After the six-month primary endpoint assessment, the study continued to assess 24-hr ABPM and OSBP from baseline through yearly follow ups. SPYRAL GEMINI Clinical Program Medtronic intends to investigate multi-organ (hepatic artery and renal artery) denervation with the Symplicity Spyral catheter. The planned Global Pilot study of r Enal and hepatic co Mb INed denervat Ion (SPYRAL GEMINI pilot study) will investigate the safety and efficacy of the multi-organ ablation approach in uncontrolled hypertension patients who are both on and off medications. "Medtronic is uniquely positioned to explore the blood pressure lowering potential of multi-organ denervation. This is supported by both its intellectual property and the Symplicity Spyral catheter design, which enables access and treatment of the Common Hepatic Artery - a vascular target rich with sympathetic innervation - with the same single catheter," said Jason Weidman, senior vice president and president of the Coronary and Renal Denervation business within the Cardiovascular Portfolio at Medtronic. "The promising preclinical data highlight the potential for interventional denervation in the liver to support additional blood pressure lowering effects of the procedure.3 This approach underscores our dedication to innovation for both patients and physicians." The utilization of Symplicity Spyral in the hepatic artery is investigational and not approved for use. GSR-DEFINE Expands to the United States Medtronic will also expand the GSR-DEFINE clinical trial to sites in the United States. 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 3,000 patients from the GSR study and enrolling up to an additional 2,000 patients globally. "This year at TCT, we are not only reinforcing the consistent, long-term effects of radiofrequency denervation, but we're further demonstrating our commitment to evidence generation and innovation," said Jason Fontana, PhD, general manager Renal Denervation, and vice president of Global Marketing for the Coronary and Renal Denervation business. "As the leader in interventional hypertension treatments, we are excited to extend the largest evidence platform available to U.S. physicians and their patients." Approved for commercial use in over 75 countries around the world, the Symplicity Spyral renal denervation system is currently limited to investigational use in Japan. About Medtronic Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit and follow Medtronic on LinkedIn. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. 1 Mahfoud F, Kandzari DE, Kario K, et al. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial. The Lancet. 2022; 399:1401-1410. 2 GSR 2024 update: Mahfoud et al.EuroPCR. 2024 3 Tzafriri, A.R., et al Morphometric analysis of the human common hepatic artery reveals a rich and accessible target for sympathetic liver denervation. Sci Rep 12, 1413 (2022). Contacts: Krystin Hayward Leong Public Relations +1-508-261-6512 Ryan Weispfenning Investor Relations +1-763-505-4626 SOURCE Medtronic plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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FDA-Approved Study Furthers Medtronic Commitment to Generate Meaningful Clinical Evidence for Use of Renal Denervation to Treat Uncontrolled Hypertension FDA-Approved Study Furthers Medtronic Commitment to Generate Meaningful Clinical Evidence for Use of Renal Denervation to Treat Uncontrolled Hypertension DUBLIN - November 8, 2018 - Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) approval to begin a clinical trial to evaluate the Symplicity Spyral(TM) renal denervation system in patients with high blood pressure (hypertension) who are already prescribed anti-hypertension medications. The SPYRAL HTN-ON MED Trial is the latest prospectively powered, randomized, sham-controlled study within the broader Medtronic SPYRAL HTN Global Clinical Program, and will evaluate a patient population comparable to what physicians typically encounter in daily practice - patients with uncontrolled blood pressure taking multiple anti-hypertensive medications. “A broad range of patients suffer with hypertension today, many of whom remain uncontrolled despite being prescribed a variety of medications; the consequences of uncontrolled hypertension represent both a substantial impact to public health and a large unmet need in medicine for new approaches,” said David Kandzari, M.D., director of interventional cardiology and chief scientific officer at Piedmont Heart Institute in Atlanta, Ga., principal investigator and member of the SPYRAL HTN Global Clinical Program Executive Committee. “This trial will add yet another critical piece to the RDN evidence basis and is designed to build on the success of our pilot study, which showed a benefit for RDN in an on-med patient population.” The design of the ON MED Trial announced today builds on the randomized sham-controlled SPYRAL HTN-ON MED pilot study that was published in The Lancet last May, showing renal denervation with the Symplicity Spyral renal denervation system - a minimally invasive, radio frequency (RF)-based procedure intended to regulate the activity of nerves that lead to and from the kidney - can play an important role in managing blood pressure for patients taking anti-hypertensive medications. The 80-patient pilot study demonstrated statistically significant and clinically relevant reductions in both office and 24-hour systolic blood pressure. Notably, those blood pressure lowering effects were observed not only throughout the daytime, but also during the nighttime and early morning periods when heart attack and stroke risk due to hypertension are highest, resulting in the observation that RDN is “always on.” The ON MED Trial is a 2:1 randomized, sham-controlled study and will randomize up to 340 patients at 55 centers in the U.S., Japan, Europe, Australia and Canada. Patients will be followed out to three years. Primary safety endpoints will include major adverse events at one month and new renal artery stenosis at six months. The primary efficacy endpoint is 24-hour ambulatory blood pressure at six months. Subjects will be prescribed a stable regimen of up to three anti-hypertensive medications, including diuretics, calcium channel blockers, ACE/ARB inhibitors or beta blockers. “Medtronic is committed to building a robust global renal denervation clinical program with results from several randomized, sham-controlled, prospectively-powered, blinded clinical studies, in both the absence and presence of prescribed medications,” said Dave Moeller, vice president and general manager of the Coronary and Renal Denervation business, which is part of the Cardiac and Vascular Group at Medtronic. “Results from the ON MED Trial will add to the growing body of evidence supporting renal denervation and is intended to support clinicians in making treatment decisions for patients who might benefit from this procedure.” Hypertension is the single largest contributor to cardiovascular death; it dramatically increases risk of heart attack, stroke, heart failure, and kidney failure. The annual direct costs of hypertension are estimated at $500 billion worldwide. It is estimated that almost 20 percent of patients are completely non-adherent to oral medications while nearly half are partially non-adherent, highlighting the need for alternative treatment options. Approved for commercial use in more than 50 countries around the world, the Symplicity Spyral system is limited to investigational use in the United States, Europe, Japan, and Canada. In addition to the ON MED trial announced today, the SPYRAL HTN Global Clinical Program also includes the SPYRAL HTN Pivotal Trial, which was announced in April and is evaluating patients in the absence of medication. For more information on the SPYRAL HTN Clinical Trial Program, visit . About Medtronic Medtronic plc ( ), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 86,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on the Securities and Exchange Commission. Actual results may differ materially from anticipated results. -end- Contacts: Joey Lomicky Public Relations +1-763-381-1204 Ryan Weispfenning Investor Relations +1-763-505-4626