ReCor Medical said today that it won an investigation device exemption from the FDA for a clinical trial of its Paradise renal denervation device for treating high blood pressure.
Palo Alto, Calif., and Amsterdam-based ReCor said the 292-patient Radiance-HTN study, a 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.
ReCor said it expects to begin enrolling patients in the U.S., U.K., France, Germany and Holland during the 1st quarter. The company raised a $15 million Series D round back in April 2015 to fund the trial of the Paradise, which is designed to use ultrasound energy to ablate the nerve endings in the lining of the renal arteries.
“Many patients across the hypertension spectrum, together with their physicians, are struggling to control their blood pressure. The Radiance-HTN trial design will allow us to evaluate the efficacy of the Paradise system in a broad population of hypertensive patients across the hypertension spectrum,” co-lead investigator Dr. Michel Azizi, of the Georges Pompidou Hospital in Paris, said in prepared remarks.
“There is strong scientific rationale for this study to evaluate renal denervation as a treatment for hypertension,” added co-principal investigator Dr. Laura Mauri of Boston’s Brigham & Women’s Hospital. “We believe that the Paradise system, with its unique combination of circumferential, ultrasound-based nerve ablation and water-based cooling for arterial protection, will be able to denervate the renal nerves with a low incidence of adverse events. Radiance-HTN’s blinded, randomized trial design, including standardization of antihypertensive treatment, will allow a robust assessment of the blood pressure reductions important to patients and their physicians.”
“FDA IDE approval of the Radiance-HTN trial positions ReCor as one of the few companies in the field investing in randomized, blinded and sham-controlled studies with the co-leadership from the hypertension and interventional physician communities,” ReCor CEO Andrew Weiss said. “We believe that this physician partnership is essential for the future establishment of RDN as a standard of care for the treatment of hypertension.”
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.