SPYRAL HTN-ON MED study shows significant, consistent, long-term blood pressure lowering effect at two years
Medtronic (NYSE: MDT) announced new two-year data from its SPYRAL HTN-ON MED clinical trial showing significant blood pressure reductions using the Symplicity™ Spyral renal denervation (RDN) system. The study demonstrated superior results compared to sham patients, with RDN group showing -12.1 mmHg reduction in 24-hr ABPM versus -7.0 mmHg in sham group. The company also announced plans for the SPYRAL GEMINI clinical trial to study multi-organ denervation, and the expansion of the GSR-DEFINE clinical trial to U.S. sites. The Symplicity Spyral system is currently approved in over 75 countries.
Medtronic (NYSE: MDT) ha annunciato nuovi dati biennali dal suo trial clinico SPYRAL HTN-ON MED, che mostrano significative riduzioni della pressione arteriosa grazie al sistema di denervazione renale Symplicity™ Spyral (RDN). Lo studio ha dimostrato risultati superiori rispetto ai pazienti di controllo, con il gruppo RDN che ha mostrato una riduzione di -12,1 mmHg nella misurazione della pressione arteriosa delle 24 ore (ABPM) contro -7,0 mmHg nel gruppo di controllo. L'azienda ha anche annunciato piani per il trial clinico SPYRAL GEMINI, che studierà la denervazione multi-organo, e l'espansione del trial clinico GSR-DEFINE presso siti negli Stati Uniti. Il sistema Symplicity Spyral è attualmente approvato in oltre 75 paesi.
Medtronic (NYSE: MDT) anunció nuevos datos de dos años de su ensayo clínico SPYRAL HTN-ON MED que muestran reducciones significativas de presión arterial utilizando el sistema de denervación renal Symplicity™ Spyral (RDN). El estudio demostró resultados superiores en comparación con los pacientes de control, con el grupo RDN mostrando una reducción de -12.1 mmHg en el monitoreo ambulatorio de 24 horas (ABPM) frente a -7.0 mmHg en el grupo de control. La compañía también anunció planes para el ensayo clínico SPYRAL GEMINI para estudiar la denervación multi-orgánica, así como la expansión del ensayo clínico GSR-DEFINE a sitios en EE. UU. El sistema Symplicity Spyral está actualmente aprobado en más de 75 países.
메드트로닉 (NYSE: MDT)은 SPYRAL HTN-ON MED 임상 시험의 새로운 2년 데이터를 발표하여 Symplicity™ Spyral 신장 신경 차단(RDN) 시스템을 사용한 знач대한 혈압 감소를 보여주었습니다. 이 연구는 대조군에 비해 우수한 결과를 보여주었으며, RDN 그룹은 24시간 혈압 모니터링(ABPM)에서 -12.1 mmHg의 감소를 나타냈고 대조군은 -7.0 mmHg의 감소를 보였습니다. 또한, 회사는 다기관 신경 차단을 연구하기 위한 SPYRAL GEMINI 임상 시험 계획과 GSR-DEFINE 임상 시험을 미국 사이트로 확장할 계획을 발표했습니다. Symplicity Spyral 시스템은 현재 75개국 이상에서 승인되었습니다.
Medtronic (NYSE: MDT) a annoncé de nouvelles données sur deux ans de son essai clinique SPYRAL HTN-ON MED montrant des réductions significatives de la pression artérielle grâce au système de déformation rénale Symplicity™ Spyral (RDN). L'étude a démontré des résultats supérieurs par rapport aux patients témoins, avec un groupe RDN montrant une réduction de -12,1 mmHg sur la mesure de la pression artérielle sur 24 heures (ABPM) contre -7,0 mmHg dans le groupe témoin. La société a également annoncé des plans pour l'essai clinique SPYRAL GEMINI pour étudier la dénervation multi-organes, ainsi que l'expansion de l'essai clinique GSR-DEFINE vers des sites aux États-Unis. Le système Symplicity Spyral est actuellement approuvé dans plus de 75 pays.
Medtronic (NYSE: MDT) kündigte neue zweijährige Daten aus seiner SPYRAL HTN-ON MED-Studie an, die signifikante Blutdrucksenkungen mit dem Symplicity™ Spyral Nieren-Denervationssystem (RDN) zeigen. Die Studie ergab bessere Ergebnisse im Vergleich zu den Kontrollpatienten, wobei die RDN-Gruppe eine Senkung um -12,1 mmHg in der 24-Stunden-Blutdruckmessung (ABPM) im Vergleich zu -7,0 mmHg in der Kontrollgruppe aufwies. Das Unternehmen kündigte außerdem Pläne für die SPYRAL GEMINI-Studie an, die die Multi-Organ-Denervierung untersuchen wird, sowie die Erweiterung der GSR-DEFINE-Studie auf US-Standorte. Das Symplicity Spyral-System ist derzeit in über 75 Ländern zugelassen.
- Significant blood pressure reductions achieved at two years (-12.1 mmHg in RDN group vs -7.0 mmHg in sham)
- Long-term safety confirmed with no serious renal artery complications
- System already commercially approved in 75+ countries globally
- Product still to investigational use in Japan
- Sham group required significantly more medications to achieve results
Insights
The SPYRAL HTN-ON MED trial results demonstrate significant clinical progress for Medtronic's Symplicity™ Spyral renal denervation system. The two-year data shows compelling efficacy with a
The expansion of clinical programs through SPYRAL GEMINI and GSR-DEFINE trials indicates strong commercial potential and market positioning. The multi-organ denervation approach could potentially create a new treatment paradigm for uncontrolled hypertension, expanding the addressable market significantly. With approval in over 75 countries, positive long-term data could accelerate market adoption and revenue growth.
This development strengthens Medtronic's position in the interventional hypertension market. The positive long-term data and expanded clinical programs could drive market penetration in the global hypertension treatment space, valued at over
The multi-organ denervation approach through SPYRAL GEMINI represents a potential competitive advantage, as Medtronic's intellectual property and catheter design uniquely position them to explore this innovative treatment method. This could lead to increased market share and revenue growth in the cardiovascular portfolio segment.
Company commits to advancing clinical data for Symplicity™ with the SPYRAL Gemini clinical trial and expansion of the GSR-DEFINE clinical trial
GALWAY,
"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 rEnal and hepatic coMbINed denervatIon (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
Medtronic will also expand the GSR-DEFINE clinical trial to sites in
"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
Approved for commercial use in over 75 countries around the world, the Symplicity Spyral renal denervation system is currently limited to investigational use in
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway,
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). https://doi.org/10.1038/s41598-022-05475-6
Contacts:
Krystin Hayward Leong
Public Relations
+1-508-261-6512
Ryan Weispfenning
Investor Relations
+1-763-505-4626
View original content to download multimedia:https://www.prnewswire.com/news-releases/spyral-htn-on-med-study-shows-significant-consistent-long-term-blood-pressure-lowering-effect-at-two-years-302288787.html
SOURCE Medtronic plc
FAQ
What were the blood pressure reduction results in Medtronic's (MDT) SPYRAL HTN-ON MED trial at 2 years?
Is Medtronic's (MDT) Symplicity Spyral system approved worldwide?
What new clinical trials is Medtronic (MDT) planning for the Symplicity Spyral system?
