{"url":"https://newsforagent.com/news/2026-11-03/medtronic-symplicity-spyral-affirm-results","markdown_url":"https://newsforagent.com/news/2026-11-03/medtronic-symplicity-spyral-affirm-results.md","title":"Medtronic Symplicity Cuts Blood Pressure in SPYRAL AFFIRM","headline":"Medtronic Symplicity Renal Denervation Lowers Blood Pressure in SPYRAL AFFIRM Study","description":"Medtronic's Symplicity Spyral renal denervation cut office systolic blood pressure by 18.2 mmHg at six months in SPYRAL AFFIRM.","section":"Research & Clinical Trials","published_at":"2026-11-03T19:55:11+00:00","modified_at":"2026-11-03T19:55:11+00:00","author":"News Desk","key_takeaways":["SPYRAL AFFIRM showed office systolic blood pressure fell 18.2 mmHg at six months with no increase in antihypertensive medications.","The FDA approved a labeling update for the Symplicity Spyral catheter covering isolated systolic hypertension, chronic kidney disease up to stage 3b and type 2 diabetes.","The composite safety endpoint occurred in 2.1% of patients, and nearly nine out of 10 experienced a clinical benefit at six months."],"companies":[{"name":"Medtronic","is_primary":true,"profile_url":"https://akta.pro/company-profiles/000076n/medtronic","website":"https://www.medtronic.com"}],"source":{"publisher":"PR Newswire","title":"TCT26: Medtronic Symplicity blood pressure procedure shows significant blood pressure drops in SPYRAL AFFIRM real-world study","url":"https://www.prnewswire.com/news-releases/tct26-medtronic-symplicity-blood-pressure-procedure-shows-significant-blood-pressure-drops-in-spyral-affirm-real-world-study-302928326.html"},"other_sources":[],"tags":["Research & Clinical Trials","Medtronic"],"body_markdown":"Medtronic said its Symplicity Spyral renal denervation system lowered office systolic blood pressure by 18.2 mmHg at six months in the SPYRAL AFFIRM post-approval study, with no increase in antihypertensive medications. The results were presented on November 3, 2026 at the Transcatheter Cardiovascular Therapeutics meeting, [PR Newswire](https://www.prnewswire.com/news-releases/tct26-medtronic-symplicity-blood-pressure-procedure-shows-significant-blood-pressure-drops-in-spyral-affirm-real-world-study-302928326.html) reported.\n\n## Inside the SPYRAL AFFIRM Six-Month Results\n\n[Medtronic](https://akta.pro/company-profiles/000076n/medtronic) is a Galway, Ireland-headquartered medical technology company that designs devices across cardiovascular, surgical robotics, neurovascular and neuromodulation therapy areas. SPYRAL AFFIRM is a prospective, multicenter, single-arm study designed with the U.S. Food and Drug Administration to gather real-world evidence in patients with uncontrolled hypertension, including women, Black American and Hispanic patients, and patients 65 and older.\n\nAt six months, home blood pressure fell 9.4 ± 13.8 mmHg and 24-hour ambulatory blood pressure fell 9.7 ± 16.8 mmHg, both with p<0.0001. Antihypertensive medication use stood at 3.6 ± 2.0 medications, unchanged from baseline, and the composite safety endpoint occurred in 2.1% of patients. Nearly nine out of 10 patients experienced a clinical benefit at six months, and a separate pooled analysis replicated that benefit at three years.\n\n\"The blood pressure reductions achieved with RDN in the AFFIRM study are transformative,\" said Dr. David Kandzari, chief of Piedmont Heart Institute and Cardiovascular Services and lead principal investigator of the study. \"Importantly, the study also demonstrated significant reductions in home blood pressure, offering insight into how patients are responding beyond the clinical setting and in their everyday lives.\"\n\n## FDA Labeling Update for Symplicity Spyral\n\nMedtronic also received FDA approval to update the labeling for the Symplicity Spyral Multi-Electrode Renal Denervation Catheter. The updated labeling adds clinical data for patients with isolated systolic hypertension, chronic kidney disease up to stage 3b (eGFR ≥30 mL/min/1.73 m²) and type 2 diabetes. The indication for use remains unchanged.\n\n\"Backed by data from SPYRAL AFFIRM and our broader clinical program, this labeling update gives physicians additional information to guide treatment decisions for patients living with hypertension and high cardiovascular risk,\" said Lara Barghout, senior vice president and president of Interventional Cardiology Therapies at Medtronic. Evidence from the SPYRAL HTN clinical program, including SPYRAL AFFIRM and the Global SYMPLICITY Registry DEFINE, supported the labeling update. The Symplicity system is approved for commercial use in more than 80 countries.\n\n## Medtronic's Recent Trial Run at TCT\n\nMedtronic reported positive real-world outcomes for its Affera Mapping and Ablation System in atrial fibrillation and ventricular tachycardia patients, along with favorable data for its PulseSelect Pulsed Field Ablation System, Yahoo reported on November 1, 2026, according to akta.pro [company records](https://akta.pro/company-data). On October 31, 2026, Medtronic presented the EXPAND TAVR II trial design at TCT, testing earlier Evolut transcatheter valve replacement with medical therapy versus medical therapy alone in moderate aortic stenosis, The future of trading reported. Medtronic announced positive real-world registry results for its Sphere-9 catheter and PulseSelect PFA System at APHRS 2026, PR Newswire reported on October 22, 2026.\n","publisher":{"name":"News for Agent","url":"https://newsforagent.com"}}