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FDA OKs pivotal study of ultrasound denervation system for hypertension
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ReCor Medical announced that the FDA has approved an investigation device exemption to conduct a pivotal study of the Paradise Ultrasound Denervation System for the treatment of hypertension.
The RADIANCE-II trial builds on recent positive results of the RADIANCE-HTN SOLO study, which were presented at EuroPCR in May. As previously reported by Cardiology Today’s Intervention, the international, single-blind, randomized, sham-controlled RADIANCE-HTN SOLO trial was conducted at 21 U.S. centers and 18 European centers and investigated whether endovascular ultrasound-based renal denervation with the Paradise system reduces ambulatory BP in patients with mild to moderate hypertension who were not using antihypertensive medication. At 2 months, the mean reduction in primary daytime ambulatory systolic BP was 8.5 mm Hg with renal denervation vs. 2.2 mm Hg with a sham procedure, resulting in a 6.3-mm Hg between-group difference (P < .0001). No safety events occurred in either arm.
The new trial will be a randomized, sham-controlled, blinded study in patients with moderate hypertension, according to a company press release. The company anticipates enrollment for the RADIANCE-II trial to begin in October.
“We have had a very constructive dialogue with the FDA during the past 9 months to craft what we believe is a strong study to develop a robust set of clinical data to support the future of FDA review for PMA approval,” Leslie Coleman, vice president of Regulatory and Medical Affairs at ReCor Medical, stated in the release. “At the time of PMA submission, we plan to have four independently-powered, blinded, sham-controlled, randomized studies of the Paradise System in patients with different stages of hypertension — our SOLO, TRIO, REQUIRE and RADIANCE-II studies — approaching a total of nearly 500 subjects, with outcomes as long as 3 years.”
Another trial of renal denervation for treatment of hypertension also gained FDA approval. In April, Medtronic announced that the FDA issued an investigational device exemption allowing the company to begin a randomized, sham-controlled pivotal trial of the Symplicity Spyral system in up to 433 patients at 50 sites in the United States, Europe, Australia and Japan. Along with the RADIANCE-HTN SOLO trial, positive results from the SPYRAL HTN-ON MED study with the Symplicity Spyral multielectrode renal denervation catheter (Medtronic) and the Symplicity G3 renal denervation radiofrequency generator were also reported at EuroPCR.
Disclosure: Coleman is an employee of ReCor Medical.