PALO ALTO, California, Oct. 30, 2017 /PRNewswire/ -- ReCor Medical announced progress milestones in the study of its Paradise® Renal Denervation System as a potential treatment for hypertension, including the 1000th consented and the 150th randomized subjects in the RADIANCE-HTN study, and publication of a study design review in the American Heart Journal. In addition, ReCor reported 40 active study centers in 6 participating countries, and progress in the Otsuka-ReCor commercial partnership in Asia.
"RADIANCE-HTN is a blinded, randomized, sham-controlled study with powered efficacy endpoints designed to demonstrate the potential beneficial blood-pressure-lowering treatment effect of renal denervation using the Paradise System," commented co-PI Laura Mauri, MD MSc of the Brigham & Women's Hospital in Boston. "The study involves two hypertensive patient groups, or "cohorts"; SOLO – for patients with hypertension who are taken off their antihypertensive medications to more precisely evaluate the BP lowering effect of renal denervation alone, and TRIO – for patients who are "resistant" to anti-hypertensive medical therapy, and to assess the additional benefit of Paradise system. RADIANCE-HTN is progressing well, we are recruiting successfully in both cohorts, and we are confident that it will produce valuable data to evaluate the efficacy of the Paradise System."
"ReCor is pleased with the progress of the RADIANCE-HTN study – in both SOLO and TRIO patient cohorts," commented Mano Iyer, ReCor Medical Founder & COO. "Working closely with our 40 study centers in the US and EU, we have achieved two major milestones: enrollment of the 1000th and randomization of the 150th study subjects. Based on our current recruitment rates, we are on plan to complete SOLO in early 2018, and TRIO in late 2018. In addition, the Steering Committee is pleased that the American Heart Journal recently published a design paper about the study, so that the broader medical community can understand its design and potential impact for future clinical treatment."
"ReCor is very pleased with the global interest in the Paradise System, the potential for device-based treatment of hypertension, and the progress in our studies in the US, EU and Asia," commented CEO Andrew M. Weiss. "RADIANCE-HTN progress is solid, and patient interest is very high in both SOLO and TRIO cohorts. Achievement of our 1000th enrollment is a key milestone - and demonstrates that together with our study-center partners, we can complete this important study and evaluate Paradise as a potential hypertension treatment. In addition, our partnership with Otsuka remains highly positive, and we are collaborating with them on their REQUIRE pivotal study of the Paradise System in Japan and Korea. We are also now beginning to explore the next phase of our clinical efforts to ensure the medical communities world-wide have the information they need to assess how Paradise may become part of the future treatment paradigm for hypertension."
More information about RADIANCE-HTN can be found at: https://clinicaltrials.gov/ct2/show/NCT02649426?term=radiance&rank=3
More information about the REQUIRE study can be found at: https://clinicaltrials.gov/ct2/show/NCT02918305?term=REQUIRE&rank=1
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). The Paradise catheter simultaneously protects the renal artery with a water-based cooling balloon and circumferentially denervates renal nerves with high intensity ultrasound energy. 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 at 40 centers in the United States and the EU.
SOURCE ReCor Medical