ReCor Medical and Otsuka Medical Devices today announced positive results from a trial of its renal denervation system for hypertension.
The Radiance II U.S. FDA investigational device exemption (IDE) pivotal trial evaluating the Paradise ultrasound renal denervation (uRDN) system as a treatment for hypertension met its primary efficacy endpoint, demonstrating a statistically significant reduction in daytime ambulatory systolic blood pressure between treatment and a sham procedure measured at two months.
ReCor Medical designed its Paradise platform as a device-based, minimally invasive procedure for treating high blood pressure. The procedure usually takes less than an hour, with the Paradise catheter placed in the renal artery.
Palo Alto, California-based ReCor Medical’s Radiance II trial, a randomized, sham-controlled trial, enrolled 224 patients with mild-to-moderate uncontrolled hypertension. Enrollees were previously treated with up to two medications and randomized while off medications at more than 60 study centers across eight countries.
Ajay Kirtane, professor of medicine at Columbia University, Vagelos College of Physicians and Surgeons / NewYork-Presbyterian Hospital and Michel Azizi, professor of medicine at Université Paris Cité, Hôpital Européen Georges Pompidou, Paris, France, were principal investigators for the study.
In a news release, Kirtane and Azizi said they were “thrilled to observe these positive results” from the Radiance II study and added that they look forward to being able to present and publish full details from the study “in the near future.”
“We at Otsuka are very pleased with the positive outcome of the Radiance II study,” Otsuka Medical Devices Executive Deputy President Kazumichi Kobayashi said in the release. “With three successful clinical trials of the Paradise uRDN system, we believe even more strongly that the Paradise system can become an important treatment option for patients and physicians struggling to control blood pressure.”
Radiance II represents the third and largest component of ReCor’s Radiance Global Program of randomized and sham-controlled studies for the Paradise uRDN system. The previous two studies, Radiance-HTN Solo and Trio, both met primary effectiveness endpoints.
“ReCor is thrilled that the Radiance II trial met its primary efficacy endpoint. Following the positive Solo and Trio clinical trials, Radiance II adds to the evidence for the Paradise system as a potential future treatment for patients with uncontrolled hypertension,” said ReCor President and CEO Andrew M. Weiss. “We would like to express our gratitude to the principal investigators, steering committee and all investigators for their efforts throughout this important trial.”
Renal denervation has become a hot space in medtech, with Medtronic also looking to enter the fray. In May, the medtech giant presented positive data for its RDN system for treating hypertension.
The results from the first 80 patients in the Medtronic Spyral HTN-ON MED trial show improved blood pressure control with significantly higher time in target range (TTR) after radiofrequency RDN when compared to sham through three years, regardless of anti-hypertensive medications.