Medtronic's Symplicity Spyral™ System Pioneers Minimally Invasive Hypertension Therapy

May 17, 2025 07:30 CST Updated 07:30

Medtronic

Medical Device Manufacturer

Click the blue words | Enter Med Wiki Device Encyclopedia, all cutting-edge information at a glance

Hypertension, as a key risk factor for cardiovascular and cerebrovascular diseases, can lead to a series of serious health conditions such as heart disease, stroke, and kidney disorders if not effectively controlled over the long term. The pathological mechanisms of its onset are complex, with the hyperactivity of the renal sympathetic nervous system being one of the significant contributing factors. Renal Denervation (RDN) is a surgical treatment specifically designed for resistant hypertension. The core mechanism of this procedure involves ablating the sympathetic nerve fibers distributed around the kidneys to suppress the overactive state of the sympathetic nervous system, thereby achieving effective blood pressure regulation.

The Symplicity Spyral™ System, developed by Medtronic, is the world’s first minimally invasive device for hypertension treatment to gain market access in the three major core regions of the United States, the European Union, and China. Based on RDN technology, the system can significantly reduce patients' blood pressure levels while ensuring treatment safety and decrease their long-term reliance on traditional antihypertensive medications.

SPYRAL Pivotal Trial¹

This was an international, prospective, single-blind controlled trial conducted at 44 research sites in Australia, Austria, Canada, Germany, Greece, Ireland, Japan, the United Kingdom, and the United States from June 25, 2015, to October 15, 2019. A total of 331 patients were randomly assigned to either renal denervation (n=166) or a sham procedure (n=165). The primary efficacy endpoint was the baseline-adjusted change in 24-hour systolic blood pressure, and the secondary efficacy endpoint was the baseline-adjusted change in office systolic blood pressure from baseline to 3 months post-procedure. Both primary and secondary efficacy endpoints were met, with posterior probabilities of superiority greater than 0.999 for both. The treatment difference between the two groups in 24-hour systolic blood pressure was -3.9 mm Hg (Bayesian 95% credible interval -6.2 to -1.6), and the difference in office systolic blood pressure was -6.5 mm Hg (-9.6 to -3.5). No device-related or procedure-related safety events occurred within 3 months. The results showed that catheter-based renal denervation significantly reduced blood pressure compared with the sham procedure in the absence of antihypertensive medications.With the advantage of safe blood pressure reduction.

Changes in 24-hour blood pressure and office blood pressure from baseline to 3 months, with data in parentheses representing 95% confidence intervals

Twenty-four-hour ambulatory systolic blood pressure (A) and diastolic blood pressure (B) at baseline and 3 months in the renal denervation group and sham control group

Symplicity Spyral™ System

The Symplicity Spyral™ system consists of the Symplicity Spyral multi-electrode ablation catheter and the SYMPLICITY G3 radiofrequency ablation generator.

The Symplicity Spyral multi-electrode ablation catheter is a radiofrequency catheter with four distributed spiral electrodes capable of achieving 360° ablation. By delivering radiofrequency energy to the intima of renal arteries, it uses thermal effects to deactivate the surrounding sympathetic nerves, maximizing complete denervation. It is suitable for vessels with diameters of 3-8mm.

The SYMPLICITY G3 Radiofrequency Ablation System, with Medtronic's unique algorithm, provides precisely controlled radiofrequency energy.Each electrode's temperature and impedance feedback can be independently assessed, and the algorithm will respond based on the monitoring data to ensure the delivery of appropriate energy.

Medtronic Company Profile

Medtronic, Inc., founded in 1949 and headquartered in Minneapolis, Minnesota, USA, is the world's largest medical technology company dedicated to providing lifelong treatment solutions for patients with chronic diseases. Medtronic's main products cover areas such as arrhythmia, heart failure, vascular diseases, heart valve replacement, extracorporeal heart support, minimally invasive heart surgery, malignant and non-malignant pain, movement disorders, diabetes, gastrointestinal diseases, urological diseases, spinal disorders, neurological diseases, and surgeries in otorhinolaryngology.

References:1. Böhm M, Kario K, Kandzari DE, Mahfoud F, et.al. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial. Lancet. 2020 May 2;395(10234):1444-1451. doi: 10.1016/S0140-6736(20)30554-7. Epub 2020 Mar 29. PMID: 32234534.

Review and Compilation: Dr. Chen Xi, Associate Chief Physician, Wuhan First Hospital

Editor: Oliver, Vascular Information

Copyright Statement: This platform aims to help healthcare professionals better understand the latest developments in relevant disease areas. The information published on this platform does not imply agreement with its descriptions or viewpoints; it is solely for providing more information. If there are any copyright issues, we kindly request the rights holders to contact us, and we will address them as soon as possible. The information is intended for healthcare professionals to stay informed and should not replace professional medical guidance in any way, nor should it be considered as medical advice. If such information is used for purposes other than staying informed, this platform and its authors shall not bear any related responsibility.Contact email for collaboration: vascular@edoctor.work.