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November 17, 2023Medtronic Announces FDA Approval of Simplicity Spyral Renal Denervation System for Treating Hypertension; Company Plans Immediate U.S. Commercial Launch
Simplicity surgery uses radiofrequency energy to ablate renal artery nerves, thereby reducing blood pressure.Medtronic's SPYRAL HTN Global Clinical Program conducted a 10-year study involving more than 25,000 patients, including those who were taking and discontinuing antihypertensive medications.The company also conducted a patient preference study, which showed that approximately one-third of patients might opt for intervention when the treatment lowers blood pressure and potential risks.
Results of the Medtronic clinical program were presented in August 2023 during a two-day FDA advisory panel meeting, alongside the results from Recor Medical, whose renal denervation system was the first of its kind to receive FDA approval for market release. (Review:Recor Medical: Paradise™ RDN Approved by FDA!）
Actually, in 2020,simplicity SpyraRenal denervation system has been usedReceived the FDA's Breakthrough Device Designation. AlthoughRenal denervation alone may not eliminate the need for medication, but it can help lower blood pressure without adding another drug to the patient’s daily regimen.# Medtronic Symplicity Spyral Once Rejected
On August 23, 2023, the Circulatory System Devices Panel of the FDA Medical Device Advisory Committee voted against Medtronic's RDN product, Symplicity Spyral. The panel unanimously agreed that the ablation catheter system is safe but unsatisfactory in terms of efficacy. Six members voted that the system's benefits outweigh its risks, six members voted against it, one panel member abstained, and the panel chair, Dr. Richard Lange, cast the decisive vote against it.Symplicity Spyral Receives FDA Approval.According to the product's recommended patient indications, the Symplicity Spyral Renal Denervation Catheter and Symplicity G3™ Radiofrequency Generator are suitable for patients with uncontrolled hypertension (whose blood pressure cannot be reduced even with antihypertensive medications) or those who have poor tolerance to antihypertensive drugs.This was also the reason that ultimately made several advisory panel members hesitant. However, members who voted against the product's efficacy and benefit-risk ratio did not believe that these studies could be used to support the patients described in the indication. On the contrary, these panel members noted that the trials were composed of patients with mild to moderate hypertension, and neither trial tested whether patients could tolerate the maximum dose of antihypertensive drugs.Medtronic has long been committed to developing minimally invasive technologies and believes this product could become a multi-billion-dollar business, offering hypertension treatment solutions to millions of patients worldwide and reducing their risk of heart attacks, strokes, and other serious events associated with high blood pressure.The same FDA review team supported the approval of ReCor Medical's RDN product the day before.ReCor Medical's clinical trial met its primary efficacy endpoint, while Medtronic's RDN trial failed to reach the goal.Symplicity Spyral is a catheter-based radiofrequency ablation device that delivers radiofrequency energy to overactive nerves in the renal arteries via an ablation catheter. The catheter is suitable for blood vessels with diameters of 3-8 mm and has four electrodes distributed in a spiral pattern at the tip, enabling 360° circumferential ablation.Symplicity Spyral has been clinically used since it received the European CE mark approval in 2013 and has now been approved and put into use in 70 countries.
In Medtronic's announcement, Dr. David Kandzari said: "The Symplicity blood pressure procedure is safe and effective, providing patients with significant and sustained reductions in blood pressure." Dr. Kandzari is the director of the Piedmont Heart Institute and Cardiovascular Services and co-principal investigator of the SPYRAL clinical program. "This landmark approval is the culmination of rigorous scientific research and clinical trials, including long-term sham-controlled studies both with and without medication, as well as the largest real-world study."Dr. Raymond Townsend, from the Hypertension Section of the Department of Internal Medicine/Nephrology at the University of Pennsylvania School of Medicine and co-principal investigator of the SPYRAL clinical program, added in the press release: "This approval paves the way for a shift in hypertension treatment, offering a solution that complements medication and lifestyle changes.""Medtronic has always believed in the potential of this therapy. Jason Weidman from Medtronic added in a company announcement: 'We are working closely with leading experts in the clinical community, who can help us bring this technology to those who need it most.' Mr. Weidman is the Senior Vice President of Medtronic's Cardiovascular Portfolio and President of the Coronary and Renal Denervation business."It is the prospect of this therapy that enables Medtronic to continue its development, even as other companies have withdrawn from the renal denervation field. Hypertension is a global health issue, and patients need more options to control their blood pressure. The approval of the Simplicity Blood Pressure Procedure marks an important milestone for both doctors and patients in the treatment of hypertension."
Editor-in-Chief | Zhao Qing Reviewed by | Yi He
