US-based medical device company ReCor Medical has started enrolling patients in the FDA IDE-approved Radiance-Htn clinical trial to assess the effect of the ReCor Paradise Renal Denervation System on blood pressure in patients with hypertension.
RADIANCE-HTN has received approval to enrol 292 subjects across 40 investigational sites, throughout the US, UK, France, Germany and the Netherlands.
Two patient groups have been selected to take part in the Radiance-Htn clinical tria, which is a blinded, randomised and sham-controlled trial to assess the ability of the Paradise system to decrease blood pressure.
The patient group, SOLO cohort will test patients with essential hypertension on two or less antihypertensive medications and the other group, TRIO cohort will test the patients with treatment-resistant hypertension on a minimum of three antihypertensive medications.
The first TRIO patient was enrolled at the Erasmus University Medical Centre in Rotterdam, Netherlands by Dr Joost Daemen.
He said: "If RADIANCE-HTN is positive, then, given the existing CE-marking, we would consider Paradise as an essential tool to treat patients with resistant hypertension here at Erasmus."
The first SOLO patient was enrolled at Sutter Health, Sacramento, US by Dr Pei-Hsiu Huang.
He said: "The SOLO cohort represents a large population of hypertension patients, many of whom are seeking alternative methods to manage a lifetime of hypertension treatment.
"We are excited to be part of this important study and by the possibility that RADIANCE-HTN could demonstrate the efficacy of renal denervation with the Paradise System, and open a path to new treatment options for our hypertension patients."
Image: An illustrated depiction of the effects of high blood pressure. Photo: courtesy of BruceBlaus.