FDA approves first renal denervation device to treat hypertension
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Key takeaways:
- The FDA approved an ultrasound renal denervation device for treatment of hypertension.
- The device is intended for use as an adjunct to lifestyle changes and medical therapy.
The FDA approved the first renal denervation device to treat adults with hypertension not adequately controlled with lifestyle changes and medications, ReCor Medical announced.
The ultrasound renal denervation system (Paradise, ReCor) lowers BP by denervating the sympathetic nerves surrounding the renal arteries, reducing the overactivity that can lead to hypertension, the company stated in a press release. The Paradise system delivers two to three doses of 360-degree ultrasound energy — lasting 7 seconds each — through each of the main renal arteries to the surrounding nerves. The Paradise catheter features a HydroCooling system, which circulates sterile water through the balloon catheter during the procedure to help protect the renal artery wall, according to the release.
As Healio previously reported, the FDA’s Circulatory System Devices Panel in August voted 10-2 that the benefits of the Paradise system outweigh any risks for use in adults with uncontrolled hypertension who are unresponsive or intolerant to antihypertensive medications and voted unanimously that the device is safe for use. In a new analysis presented at TCT 2023, pooled data from three studies demonstrated a maintained BP-lowering effect with fewer added medications after treatment with the ultrasound renal denervation system compared with a sham procedure.
“Current control rates for hypertension are dismal, and this technology offers a new option for many patients with resistant or difficult-to-control hypertension,” Naomi D.L. Fisher, MD, director of hypertension services and the hypertension specialty clinic at Brigham and Women’s Hospital, told Healio after the announcement of the approval. “Ultrasound renal denervation has been proven safe and effective in rigorous studies. When lifestyle changes and medications are not enough, ultrasound renal denervation holds great promise as an adjunctive therapy to help patients reach their goal BP.”
ReCor conducted three independent clinical studies —RADIANCE-HTN SOLO and RADIANCE-HTN TRIO and the pivotal study, RADIANCE-II — evaluating the renal denervation system in patients with uncontrolled hypertension. All three trials were randomized, double-blind and sham-controlled. In SOLO and RADIANCE-II, participants were taken off antihypertensive medications 4 weeks prior to randomization; in TRIO, participants received a standardized hypertension medication regimen (triple pill) 4 weeks before randomization. For all three trials, the primary safety endpoint was a composite of major adverse events and the primary effectiveness endpoint was the difference between the treatment and sham groups in baseline-adjusted reduction in daytime ambulatory systolic BP at 2 months after the procedure. The ultrasound renal denervation system received an FDA breakthrough device designation in December 2020.
In RADIANCE-II, at 2 months, daytime ambulatory systolic BP declined 7.9 mm Hg in the renal denervation group and 1.8 mm Hg in the sham group, for a between-group difference in means of –6.3 mm Hg (95% CI, –9.3 to –3.2; P < .0001). Those results were consistent with the findings in SOLO and TRIO, confirming that ultrasound renal denervation lowers BP across the spectrum of hypertension, the company stated in the release. In 2018, the Circulatory System Devices Panel recommended a 5 mm Hg to 7 mm Hg relative BP reduction in renal denervation-treated patients vs. controls as a clinically meaningful threshold for effectiveness, according to the FDA.
“There are many patients with hypertension refractory to multiple medications, and with multiple hospitalizations and even a prior stroke due to uncontrollable BP,” Ajay Kirtane, MD, SM, director of Columbia Interventional Cardiovascular Care, told Healio. “To at least have some hope that we may be able to control their BP better is so gratifying. There are many patients with BP that is uncontrolled despite the best efforts at lifestyle modification and medications. The approval of a renal denervation device offers clinicians the ability to offer a device-based adjunct to their care that may help them be better controlled.”
“Recor is leading the way in bringing an innovative solution to clinicians and their patients struggling to control blood pressure. This FDA approval is the culmination of years of technical research and rigorous clinical studies,” Lara Barghout, president and CEO of Recor Medical, said in the release. “We are grateful to the patients who participated in the studies and to the clinical trial investigator teams whose diligence and dedication made FDA approval possible. We look forward to making this technology available to physicians and their patients nationwide.”
The Paradise system is one of two renal denervation devices that was under consideration for approval by FDA. In a separate August meeting, a slim majority of FDA advisory panelists voted that the benefits of a radiofrequency renal denervation system (Symplicity Spyral, Medtronic) did not outweigh the risks for use in adults with uncontrolled hypertension despite use of antihypertensive medications. An FDA decision on the radiofrequency renal denervation device is expected in 2023.
The Paradise system previously received a CE mark and is an investigational device in Japan.
For more information:
Naomi D.L. Fisher, MD, can be reached at nfisher@bwh.harvard.edu.
Perspective
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Keith C. Ferdinand, MD, FACC, FAHA, FASPC, FNLA
Anytime we have a new device or pharmacotherapy agent for hypertension, I consider it a positive development for patients. Hypertension is the most potent and prevalent CV risk factor, and is especially found in older persons, people with diabetes, chronic kidney disease and non-Hispanic Black adults. The main reason for the increasingly poor control of BP is lack of intensification of therapy, combined with suboptimal adherence and the adverse effects of the social determinants of health. Nevertheless, for patients who need assistance with lowering their BP, despite optimal efforts at therapeutic lifestyle changes and pharmacotherapy, the Paradise system is a significant adjunctive treatment option.
The ideal candidates for renal denervation have yet to be realized. It will likely be patients with good adherence and BP poorly controlled despite being prescribed two or perhaps three medications at optimal doses, one of which should be a thiazide-type diuretic. In these patients, the renal nerve catheter does not remove the need for pharmacotherapy. But it will help simplify therapy and, along with combination pills, perhaps give more consistent BP control in the long-term with less difficulty maintaining appropriate adherence.
I do not expect that in patients with more difficult to treat or resistant hypertension that this device will eliminate the need for medicines. Patients should recognize that there is no one approach and most patients will be continued on an antihypertensive regimen, even if simplified or reduced by this innovative approach.
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