Results on ReCor Medical’s Paradise ultrasound renal denervation system published in two JAMA Network publications

ReCor Medical and parent company, Otsuka Medical Devices, have announced that primary endpoint results from the RADIANCE II pivotal trial have been published in the Journal of the American Medical Association (JAMA). Study results showed that the Paradise ultrasound renal denervation (uRDN) system successfully reduced blood pressure compared to sham. In addition, pooled analysis results from the combined primary efficacy endpoint and safety data from RADIANCE SOLO, RADIANCE TRIO, and RADIANCE II were concurrently published, showing a consistent blood pressure-lowering effect across a range of hypertension.

RADIANCE II IS A RANDOMISED, sham-controlled US Food and Drug Administration (FDA) investigational device exemption pivotal trial of the Paradise uRDN system for treating patients with uncontrolled hypertension.

Conducted as an international multicentre study at more than 60 study centres in eight countries, 224 patients with uncontrolled hypertension were randomised 2:1 to uRDN or a sham. Patients were to remain off antihypertensive medications throughout the two months of followup unless specified blood pressure criteria were exceeded. At the two- month primary efficacy endpoint, patients treated with the Paradise uRDN system had a mean reduction in daytime ambulatory systolic blood pressure of -7.9mmHg, compared to a reduction of -1.8mmHg in the sham arm, corresponding to a statistically significant and clinically relevant between-group difference of -6.3mmHg (p<0.0001). The study also achieved its primary safety composite outcome with no major adverse events observed.

Concurrently published in JAMA Cardiology, the RADIANCE pooled analysis includes data from more than 500 patients randomised in the three studies from RADIANCE-HTN TRIO, of hypertension-mediated organ damage, should be followed when considering renal denervation as a treatment option.

Furthermore, they state that interventionalists require expertise in renal interventions and specific training in renal denervation procedures. “Centres performing these procedures require the skills and resources to deal with potential complications,” Barbato et al state.

Presently both the Symplicity Spyral and Paradise system carry a CE mark, and Medtronic and ReCor both filed premarket approval applications to the US Food and Drug Administration (FDA) in late 2022 for their respective devices.

“To date, there are at least 18 societal and/or expert consensus documents published, and the increasing number of citations seems to parallel the mounting evidence for renal denervation therapy,” David Kandzari (Piedmont Heart Institute and Cardiovascular Services, Atlanta, USA), a member of the writing committee for the ESC/EAPCI consensus statement and prinicipal investigator in the SPYRAL HTN-ON MED trial, told Interventional News. “In all, these documents are important for providing clinicians with guidance regarding the evidence basis for renal denervation safety and effectiveness, patient selection, and procedural technique. Many of the documents also underscore the need for shared-decision making and accounting for patient preference.

“The ESC/EAPCI document offers the most contemporary evidence and informed clinical considerations for renal denervation, including recommendations for not only patient selection but also for institutions related to renal denervation programme development, patient selection, and operator proficiency.” which studied patients with resistant hypertension, and RADIANCE-HTN SOLO and RADIANCE II, which studied patients with mildmoderate hypertension.

The combined dataset showed an overall reduction in daytime ambulatory systolic blood pressure in the uRDN group of -8.5mmHg with a difference between treatment and sham at two months of -5.9mmHg (p<0.0001), favouring uRDN. Blood pressure results were similarly positive in the 24-hour, night-time, home, and office measures. A favourable safety profile was consistently observed post-uRDN treatment across the studies.

“The results of the RADIANCE clinical trials are meaningful in that they solidify the role of the Paradise uRDN system as a therapy for hypertension treatment in addition to medications and lifestyle modification. Having three consistent sham-controlled clinical trials demonstrating the Paradise uRDN system can safely lower blood pressure in a range of patients is a very high bar to have met,” said co-principal investigator Ajay Kirtane (New York-Presbyterian Hospital, New York, USA).

Co-principal investigator Michel Azizi (Université Paris Cité, Hôpital Européen Georges Pompidou, Paris, France) added: “The results [of the pooled analysis] are in line with the 2023 consensus statement of the European Society of Cardiology (ESC) Council on Hypertension and the European Association of Percutaneous Cardiovascular Interventions (EAPCI). The publication of these results will bring the evidence of the performance of uRDN in the treatment of hypertension to a broad audience of physicians.”