PALO ALTO, Calif., May 17, 2018 / — ReCor Medical announced today that it will present the primary outcomes data from the SOLO study of its RADIANCE Global Clinical Trial Program of the Paradise™ Ultrasound Renal Denervation System for patients with hypertension during the Late Breaker Sessions at the EuroPCR 2018 Meeting in Paris on 23 May.
The RADIANCE Global Clinical Trial Program includes RADIANCE-HTN, ReCor’s randomized study of the Paradise Renal Denervation System in hypertensive patients in the US and Europe and the REQUIRE study of the Paradise System in resistant hypertensive patients in Japan and Korea. RADIANCE-HTN involves two study Cohorts: “SOLO” – whose subjects studied in the absence of anti-hypertensive medications, and “TRIO” – whose subjects are studied on a standardized anti-hypertensive medication. Both Cohorts are randomized, blinded, sham-controlled, and independently powered for efficacy. Randomization of the RADIANCE-HTN SOLO cohort study was completed in December, 2017, while the TRIO cohort is currently enrolling in 35 centers in the US and Europe.
The SOLO Cohort primary results will be presented during the Late Breaker Sessions at EuroPCR on May 23rd in Paris, France, by Co-Principal Investigator Laura Mauri, MD, MSc, Brigham & Women’s Hospital, Boston, MA. In addition, ReCor Medical is sponsoring an RDN Symposium on the same day, with additional analysis, technical review and initial assessment of clinical impact of the SOLO results provided by Michel Azizi, MD, George Pompidou Medical Center (co-PI); Felix Mahfoud, MD, University Hospital Saarland; Roland Schmieder, MD, University Hospital Erlangen; Ajay Kirtane, MD, Columbia University Medical Center and Dr. Mauri.
“We are very pleased to be able to present the SOLO primary outcome data at the EuroPCR meeting, and to have such a distinguished panel of hypertension specialists and cardiologists review the potential impact of the Paradise System in the treatment of hypertension,” commented Andrew M. Weiss, ReCor, President & CEO. “During the past two years more than 500,000 patients sought information about the RADIANCE-HTN study – a strong indication of patient interest in device-based hypertension treatment. With the completion of the primary outcome phase of our SOLO study, and continued progress in the TRIO cohort of RADIANCE-HTN, we are optimistic about the continued progress of study of the Paradise System, to support the potential for future clinical use.”
About ReCor Medical, Inc.
ReCor Medical is a private, development-stage, medical device company with the Paradise™ System, a proprietary, ultrasound-based system for intravascular denervation of the renal nerves (RDN). RDN is a potential therapeutic option for treatment of hypertension, one of the most prevalent medical conditions. The Paradise System bears a CE mark but is not approved for sale in the United States. ReCor is conducting the RADIANCE-HTN clinical trial under an IDE from the US FDA in the United States and Europe.