ReCor Medical has been granted US Food and Drug Administration investigational device exemption approval for the RADIANCE-HTN clinical trial. This trial will measure the effect of ReCor’s Paradise renal denervation system on blood pressure, in patients with hypertension.
The blinded, randomised and sham-controlled trial will evaluate the effects of the system on the blood pressure of 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 will be led by two co-primary investigators; Michel Azizi, Georges Pompidou Hospital, Paris, France, and Laura Mauri, Brigham & Women’s Hospital, Boston, USA. The study is approved to enrol 292 patients at up to 40 investigational sites, and will be conducted in the USA, UK, France, Germany, and The Netherlands. Initial patient enrolment is anticipated in the first quarter of 2016.
Azizi comments, “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.”
“There is strong scientific rationale for this study to evaluate renal denervation as a treatment for hypertension,” adds Mauri. “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. RADIANCE-HTN’s blinded, randomised trial design, including standardisation of antihypertensive treatment, will allow a robust assessment of the blood pressure reductions important to patients and their physicians.”