ReCor Medical’s Paradise Renal Denervation System Receives FDA Breakthrough Device Designation

December 10, 2020—ReCor Medical, Inc., a wholly owned subsidiary of Otsuka Medical Devices, announced that its catheter-based Paradise ultrasound renal denervation system has received FDA Breakthrough Device designation for the treatment of patients with uncontrolled hypertension who are not sufficiently responsive, or are intolerant, to antihypertensive medical therapy. Additionally, the company announced that the Paradise system demonstrated positive results in the RADIANCE-HTN TRIO study.

ReCor noted that the FDA Breakthrough Devices program is intended to help patients receive more timely access to breakthrough medical technologies that have the potential to provide more effective treatment for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide ReCor with priority review and interactive communication during the premarket review process.

The Paradise system is an investigational device in the United States and has been studied in RADIANCE-SOLO and RADIANCE-TRIO—the two cohorts of RADIANCE-HTN, the FDA investigational device exemption (IDE) clinical trial. ReCor is currently conducting RADIANCE-II HTN, an FDA IDE pivotal study for patients with uncontrolled hypertension.

According to the company, the RADIANCE-HTN TRIO trial evaluated the efficacy and safety of the Paradise system to reduce blood pressure in hypertensive patients (n = 136). In the trial, all patients were placed on a single-pill combination of three antihypertension medications (a calcium-channel blocker, an angiotensin II-receptor blocker, and a diuretic). After confirmation of inadequately controlled hypertension despite these medications, patients were then randomly assigned to Paradise system treatment or a sham procedure.

The trial met its primary efficacy endpoint of a greater reduction in daytime blood pressure between baseline and 2-month follow-up with the Paradise system as compared with the sham procedure. Detailed analyses are being prepared for presentation and publication in 2021, advised ReCor Medical.

Ajay J. Kirtane MD, Professor of Medicine at the Columbia University Vagelos College of Physicians and Surgeons in New York, New York, serves as Coprincipal Investigator of the trial. Dr. Kirtane commented in ReCor Medical’s press release, “The RADIANCE-HTN TRIO results very nicely complement the previously presented RADIANCE-HTN SOLO trial data, now demonstrating efficacy of renal denervation in a higher-risk cohort of patients with treatment-resistant hypertension. On behalf of my Coprincipal Investigator Professor Michel Azizi, MD, and the entire steering committee, I would like to thank the study patients, investigators, and coordinators from more than 50 study centers in seven countries who gave so much of themselves in order to complete this rigorously conducted trial, especially in the throes of a pandemic. We eagerly look forward to fully presenting and publishing the data in the near future.”