ReCor Medical, a private, venture-backed, medical device company,  has initiated the enrollment of the first subjects in the FDA IDE-approved 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 a blinded, randomized and sham-controlled trial designed to evaluate the blood pressure lowering effect of the Paradise System in two patient populations: the SOLO cohort will evaluate subjects with essential hypertension on two or fewer antihypertensive medications, and the TRIO cohort will evaluate subjects with treatment-resistant hypertension on a minimum of 3 antihypertensive medications.

The first TRIO patient was enrolled at the Erasmus University Medical Center in Rotterdam, the Netherlands by Dr. Joost Daemen. "We are excited to have enrolled the first patient in this very important study," commented Dr. Daemen. "We have significant experience using the Paradise System and believe that the RADIANCE-HTN study is well designed to demonstrate the System's treatment effect.  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, CA, USA by Dr. Pei-Hsiu Huang. "The SOLO cohort represents a large population of hypertension patients, many of whom are seeking alternative methods to manage a lifetime of hypertension treatment," added Dr. Huang. "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."

RADIANCE-HTN is approved to enroll 292 subjects at up to 40 investigational sites, and will be conducted in the US, UK, France, Germany, and The Netherlands.

ReCor Medical is a private, venture-backed, medical device company that designs and manufactures a proprietary ultrasound ablation system for renal denervation (RDN). RDN is a new potential therapeutic approach for the treatment of hypertension, one of the most prevalent medical conditions.