FDA Approves IDE for RADIANCE-HTN Trial of ReCor's Paradise Renal Denervation System

February 22, 2016—ReCor Medical announced that it has received approval for an investigational device exemption from the US Food and Drug Administration for the RADIANCE-HTN clinical trial to evaluate the effect of the ReCor Paradise renal denervation system on blood pressure in patients with hypertension.

According to the company, RADIANCE-HTN is a blinded, randomized, and sham-controlled trial designed to evaluate the blood pressure lowering effect of the Paradise system in two patient populations: (1) patients with essential hypertension on two or fewer antihypertensive medications, and (2) patients with treatment-resistant hypertension on a minimum of three antihypertensive medications.

RADIANCE-HTN will be led by two coprimary investigators: Prof. Michel Azizi, MD, of Georges Pompidou Hospital in Paris, France, and Laura Mauri, MD, of Brigham & Women's Hospital in Boston, Massachusetts. The study is approved to enroll 292 patients at up to 40 investigational sites in the United States, the United Kingdom, France, Germany, and the Netherlands. Initial patient enrollment is anticipated to begin in the first quarter of 2016.

The company stated that the Paradise system’s intravascular catheters denervate renal nerves by combining the protection of water-based cooling of the renal artery with high-intensity ultrasound energy for circumferential renal nerve ablation.

ReCor’s Paradise system has received CE Mark approval for sale in the European Union. The device is not approved for sale in the United States, advised the company.

In the company’s press release, Prof. Azizi commented, “Many patients across the hypertension spectrum, together with their physicians, are struggling to control their blood pressure. The RADIANCE-HTN trial design will allow us to evaluate the efficacy of the Paradise system in a broad population of hypertensive patients across the hypertension spectrum.”

Dr. Mauri added, “There is strong scientific rationale for this study to evaluate renal denervation as a treatment for hypertension. We believe that the Paradise system, with its unique combination of circumferential, ultrasound-based nerve ablation and water-based cooling for arterial protection, will be able to denervate the renal nerves with a low incidence of adverse events.”

Dr. Mauri further noted, “RADIANCE-HTN's blinded, randomized trial design, including standardization of antihypertensive treatment, will allow a robust assessment of the blood pressure reductions important to patients and their physicians.”