View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
April 10, 2016

ReCor Medical begins enrollment in Radiance-Htn hypertension trial of ReCor Paradise Renal Denervation System

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.

ReCor

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.

"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"

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.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Medical Device Network