The blinded, randomized and sham-controlled trial is designed to evaluate the Paradise system in patients with essential hypertension taking 2 or fewer medications and patients with treatment-resistant hypertension on a minimum of 3 drugs. The trial has 2 arms: The Solo cohort is designed to evaluate the essential hypertension patients; the Trio cohort will study the treatment-resistant group, Palo Alto, Calif., and Amsterdam-based ReCor said.
“We are excited to have enrolled the first patient in this very important study,” Dr. Joost Daemen, who enrolled the 1st Trio patient at the Erasmus University Medical Center in Rotterdam, Holland, said in prepared remarks. “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 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. Pei-Hsiu Huang, who enrolled the 1st Solo patient at Sacramento’s Sutter Health. “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.”
ReCor won an investigation device exemption from the FDA for the trial in February. The company raised a $15 million Series D round back in April 2015 to fund the study of Paradise, which is designed to use ultrasound energy to ablate the nerve endings in the lining of the renal arteries.
ReCor, Boston Scientific (NYSE:BSX), St. Jude Medical (NYSE:STJ) and Medtronic (NYSE:MDT) are all back in the renal denervation game, 2 years after Medtronic announced its Symplicity-3 renal denervation device missed its primary endpoint. Boston Scientific delayed its Vessix program in immediate response, and St. Jude Medical (NYSE:STJ) suspended its own trial. Eventual Medtronic acquisition Covidien ceded the field entirely, winding down development of its OneShot renal denervation device, which already had E.U. regulatory approval, and closing its Rapid II trial.
But the same month that ReCor announced its Series D round, Medtronic launched a new RDN trial, aiming to settle the “confounding” issues raised during Symplicity-3. Boston Scientific is running 2 clinical programs for its Vessix device: The Reduce trial, evaluating Vessix in treating hypertension; and the Relieve series, evaluating the technology for other conditions, including end-stage renal disease, heart failure, atrial fibrillation and diabetes. And St. Jude is running trials of its EnligHTN device in hypertension.