ReCor Medical has 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.
RADIANCE-HTN is an IDE-approved, blinded, randomized and sham-controlled trial 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 3 antihypertensive medications.
RADIANCE-HTN is led by Professor Michel Azizi, MD PhD (Georges Pompidou Hospital, Paris, France) and Dr. Laura Mauri, MD, MSc (Brigham & Women's Hospital, Boston, MA). The study is IDE-approved to enroll 292 patients and is being conducted in the US, UK, France, Germany, and The Netherlands.
ReCor announced that RADIANCE-HTN is actively enrolling in 25 study centers in the five countries indicated above, with an additional 15 centers planning to join by year's end. More than 100 patients have been enrolled to date.
"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," added Co-PI Dr. Mauri.
"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."
ReCor also 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.
"We at ReCor are very pleased with the progress we have made in our global effort to study the Paradise System in patients with hypertension," commented Andrew M. Weiss, President & CEO of ReCor Medical.
"When viewed together, in cooperation with our partners at Otsuka, we have a three-continent effort to study Paradise in patients with both essential and treatment-resistant hypertension, one of the most important efforts in this field today."