ReCor Medical Updates Progress in Trials for Paradise Renal Denervation System
November 2, 2016—ReCor Medical, Inc. recently announced key milestones in its 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 an investigational device exemption trial approved by the US Food and Drug Administration to enroll 292 patients. It is being conducted in the United States, United Kingdom, France, Germany, and the Netherlands. Currently, RADIANCE-HTN has enrolled more than 100 patients at 25 centers in these five countries. An additional 15 centers are planning to join by the end of the year.
The randomized, blinded, and sham-controlled trial is designed to evaluate the blood pressure lowering effect of the Paradise system in two patient populations: those with essential hypertension on two or fewer antihypertensive medications, and those with treatment-resistant hypertension on a minimum of three antihypertensive medications. ReCor Medical 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.
RADIANCE-HTN is led by Professor Michel Azizi, MD, of Georges Pompidou Hospital in Paris, France and Laura Mauri, MD, of Brigham & Women's Hospital in Boston, Massachusetts.
In the company’s press release, Dr. Mauri commented, “We are pleased with the progress of RADIANCE-HTN and understand that we are involved in an important effort: to evaluate the efficacy of renal denervation with the Paradise system in patients with hypertension. We have seen that both physicians and patients are keenly interested in the potential of the Paradise treatment. Our focus for the coming year will be to consent and randomize eligible study subjects and ensure that the RADIANCE-HTN results reflect the true performance of Paradise in the study.”
Additionally, ReCor announced that its commercial partner in Asia, Otsuka Holdings, has initiated the REQUIRE study of the Paradise system in Japan. REQUIRE is a randomized, sham-controlled, pivotal study of the Paradise system in patients with treatment-resistant hypertension on three or more antihypertensive medications.
The Paradise system has received European CE Mark approval. It is not approved for sale in the United States.