ReCor Medical announced the FDA had granted the company an investigational device exemption approval for a trial to evaluate the effect of the ReCor Paradise Renal Denervation System on blood pressure in patients with hypertension.
The system is not yet FDA-approved, but it is available for sale in Europe.
The randomized, double-blind, sham-controlled RADIANCE-HTN trial will test the system in two cohorts. The first will enroll patients who have essential hypertension and take two or fewer antihypertensive medications, while the second will include patients who have treatment-resistant hypertension and take at least three antihypertensive medications.
The study will enroll an estimated 292 adults between 18 and 75 years old at up to 40 sites in the U.S., United Kingdom, France, Germany and the Netherlands beginning in the first quarter of 2016. The study will be completed in July 2020.
Michael Azizi, MD, PhD, of Georges Pompidou Hospital in Paris and Laura Mauri, MD, MSc, of Brigham & Women’s Hospital in Boston are the co-primary investigators.
The primary outcome will be the mean reduction in average daytime ambulatory systolic blood pressure from baseline to two months post-procedure.
Patients randomized to the treatment arm will receive the renal denervation procedure using the Paradise system to deliver ultrasound energy to thermally ablate and disrupt the renal sympathetic nerves while sparing the renal arterial wall, according to a description posted on ClinicalTrials.gov.
ReCor Medical, which was founded in 2009, has international headquarters in Amsterdam, Netherlands, and U.S. headquarters in Palo Alto, California.