FDA approves second renal denervation device to treat hypertension
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Key takeaways:
- The FDA approved a radiofrequency renal denervation device for treatment of hypertension.
- An FDA advisory panel in August voted that the benefits of the radiofrequency device did not outweigh the risks.
The FDA approved a second renal denervation device to treat adults with uncontrolled hypertension despite an advisory panel’s vote regarding that system’s risks and benefits, Medtronic announced.
The approval of the radiofrequency renal denervation system (Symplicity, Medtronic) comes after a slim 7-6 majority of FDA advisory panelists in August rejected that the benefits of the minimally invasive system outweigh the risks for use in adults with uncontrolled hypertension despite the use of antihypertensive medications. Panelists also voted 7-6 that the system is effective for use in patients with uncontrolled hypertension and unanimously supported the device’s safety. During the meeting of the FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee, some panelists expressed concerns about a modest reduction in BP with the device, as well as the potential for device overuse among clinicians.
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"We appreciate the robust conversation that occurred prior to the vote," Jason Weidman, senior vice president and president of the coronary and renal denervation business at Medtronic, said in a press release. "We will continue to collaborate with the FDA on bringing a new option to the millions of people living with high blood pressure.”
The FDA decision marks the second approval this year of a renal denervation system for adults with hypertension not adequately controlled with medication and lifestyle; the first approval was for an ultrasound renal denervation system (Paradise, ReCor Medical) in early November.
Debate over smaller BP reductions
The Symplicity approval is primarily based upon two studies, SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED, both prospective, sham-controlled, single-blind randomized studies conducted in the U.S., Canada, Japan, Europe and Australia.
SPYRAL HTN-OFF MED enrolled adults with hypertension whose medications could be discontinued at the start of the trial. The primary effectiveness endpoint was the mean difference in baseline-adjusted 24-hour ambulatory systolic BP (ASBP) from baseline to 3 months after renal denervation or the sham procedure. That study showed a statistically significant reduction of 3.9 mm Hg ASBP among participants in the radiofrequency renal denervation arm vs. sham controls.
SPYRAL HTN-ON MED enrolled adults with uncontrolled hypertension with BP medications continued during the trial. The primary endpoint was the mean difference in the baseline-adjusted 24-hour ASBP at 6 months after renal denervation or the sham procedure. That study showed a nonsignificant 0.03 mm Hg ASBP reduction among participants in the renal denervation arm vs. sham controls, not meeting its primary endpoint.
Medtronic attributed the results to changes that occurred among patients in the sham group. Researchers identified a 10-fold difference in changes in medications that would favor BP lowering in the sham control group, which researchers said was an unexpected reduction not observed in previous studies.
“That has been the real challenge, mixing two different ways to lower BP and trying to tease out the effects of one method, renal denervation, vs. the standard, medication method,” Raymond R. Townsend, MD, FAHA, professor of medicine and director of the Hypertension Program at the Hospital of the University of Pennsylvania and a co-principal investigator of the SPYRAL program, told Healio before the FDA’s decision. “We have shown with more than 7,000 patients in clinical trials over the last 11 to 12 years that renal denervation does lower BP, with or without medication present.”
Renal denervation for BP lowering attracted much interest from researchers and industry in the early 2010s, until the failure a pivotal trial of the first version of the Symplicity device in 2014. After that, some companies abandoned their renal denervation programs and others redesigned their technologies to make them more effective.
A ‘groundbreaking advancement’
In a separate release, the Society for Cardiovascular Angiography and Interventions (SCAI) hailed the two renal denervation device approvals as a “groundbreaking advancement” in the treatment of patients with uncontrolled hypertension, noting that the two approvals mark a “significant milestone in the field of cardiovascular medicine.”
"The approval of the renal denervation systems by the FDA is a game-changer for both interventional cardiology and the treatment of hypertension," George D. Dangas, MD, PhD, president of SCAI, professor of medicine and surgery at Icahn School of Medicine at Mount Sinai and director of cardiovascular innovation at the Zena and Michael A. Wiener Cardiovascular Institute at the Icahn School of Medicine at Mount Sinai, said in the release. "This innovative technology has the potential to revolutionize how we approach the management of high blood pressure which has grown tremendously globally, offering patients a safe and effective treatment option."
In August, SCAI released a position statement on renal denervation for hypertension highlighting ideal patient selection, best practices for optimal techniques, competence, training and organizational recommendations.
“We need to focus our efforts on those in whom we have ruled out secondary causes of hypertension, have optimized both lifestyle and medical therapies and, despite that, have not been able to get people to goal,” Herbert D. Aronow, MD, MOH, FACC, FSCAI, FSVM, medical director of heart and vascular services, the Benson Ford Chair in Cardiology at Henry Ford Health and chair of the SCAI writing group, told Healio in an interview before the FDA’s decision. “There may be some patients in whom this procedure might replace an [antihypertensive] agent or two. For most patients, this is going to help get someone to goal or perhaps reduce the need for a medication. It will not completely replace an entire medical regimen.”
Aronow said that small reductions in BP, even 2 to 3 mm Hg, will likely translate into “substantial reductions” in risk for CV events, including MI and stroke.
“Based on the wealth of data we have on ultrasound and radiofrequency renal denervation, we have seen efficacy and safety in the short term and durability out to 3 years,” Aronow told Healio. “From a real-world registry, we see continued effectiveness and no signal for harm up to 5 and even 10 years. The data in aggregate suggest durability.”
The Symplicity system is approved for commercial use in more than 70 countries and is limited for investigational use in Canada, China and Japan. Medtronic stated in the release that it will immediately begin commercialization of the renal denervation system in the U.S.
Reference:
For more information:
Herbert D. Aronow, MD, MOH, FACC, FSCAI, FSVM, can be reached at haronow1@hfhs.org.
Raymond R. Townsend, MD, FAHA, can be reached at townsend@upenn.edu.
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