PALO ALTO, Calif., Dec. 10, 2020 /PRNewswire/ -- ReCor Medical, Inc. ("ReCor"), a wholly-owned subsidiary of Otsuka Medical Devices, announced today that its Paradise™ Ultrasound Renal Denervation System (the "Paradise System") demonstrated positive results in the RADIANCE-HTN TRIO ("TRIO") study, and, separately, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with uncontrolled hypertension who are inadequately responsive to anti-hypertensive medications.
The RADIANCE-HTN TRIO trial evaluated the efficacy and safety of the Paradise System – a catheter-based system designed to denervate the renal nerves with ultrasound energy – to reduce blood pressure in hypertensive patients (n=136) wherein all subjects were placed on a single-pill combination-drug containing 3 anti-hypertension medications (a calcium-channel blocker, an angiotensin II-receptor blocker, and a diuretic). After confirmation of inadequately controlled hypertension despite these medications, patients were then randomly assigned to Paradise System treatment or a sham (placebo) procedure.
The trial met its primary efficacy endpoint of a greater reduction in daytime blood pressure (Daytime ABPM) between baseline and 2-month follow-up with the Paradise System as compared with the sham procedure.
"ReCor is very pleased with the TRIO outcomes, which demonstrate a clear Paradise treatment effect versus sham," commented President & CEO, Andrew M. Weiss. "ReCor believes that TRIO is a unique randomized, sham-controlled study in hypertension given the use of single pill triple medication to set a common baseline medication level in all study subjects, thus helping to establish that the Paradise RDN procedure can provide an additional clinical benefit to patients who are resistant to anti-hypertensive medications."
"The RADIANCE-HTN TRIO results very nicely complement the previously presented RADIANCE-HTN SOLO trial data, now demonstrating efficacy of renal denervation in a higher-risk cohort of patients with treatment-resistant hypertension," commented co-principal investigator Ajay J. Kirtane MD, SM, Professor of Medicine at the Columbia University Vagelos College of Physicians and Surgeons. "On behalf of my co-principal investigator Professor Michel Azizi and the entire steering committee, I would like to thank the study patients, investigators, and coordinators from more than 50 study centers in 7 countries who gave so much of themselves in order to complete this rigorously conducted trial, especially in the throes of a pandemic. We eagerly look forward to fully presenting and publishing the data in the near future."
Additional, detailed analyses are being prepared for presentation and publication in 2021.
Separately, ReCor received notice from the US FDA that the Paradise System has been granted designation as a Breakthrough Device for the treatment of hypertensive patients who may not be sufficiently responsive, or are intolerant, to anti-hypertensive medical therapy. The FDA Breakthrough Devices Program is intended to help patients receive more timely access to breakthrough medical technologies that have the potential to provide more effective treatment for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide ReCor with priority review and interactive communication during the premarket review process.
"ReCor is pleased that the FDA granted the Breakthrough Designation to the Paradise System," commented Leslie Coleman, Vice President of Regulatory and Medical Affairs at ReCor. "ReCor believes that Paradise is truly innovative and has the potential to provide an important and innovative therapy option to hypertensive patients worldwide."
The Paradise System is an investigational device in the United States and has been studied in two FDA IDE clinical trials, RADIANCE-SOLO and RADIANCE-TRIO. ReCor is currently conducting an FDA IDE pivotal study (RADIANCE-II HTN) in patients with uncontrolled hypertension.
Hypertension is one of the leading contributors to disease burden worldwide, leading to increased cardiovascular morbidity and mortality, poorer quality of life, and increased cost burden to health systems.
About ReCor Medical, Inc.
ReCor Medical, headquartered in Palo Alto, CA, is a medical technology company focused on transforming the management of hypertension, the leading cardiovascular risk factor in the world. ReCor has pioneered the minimally invasive use of ultrasound in renal denervation, and developed the Paradise® System, to treat patients with hypertension. Paradise is an investigational device in the United States. It is approved for sales in the EU and bears a CE mark. The company has completed two ID randomized, controlled studies of Paradise in patients with both moderate hypertension and those resistant to standard medical therapies. ReCor is currently conducting its FDA IDE pivotal study, RADIANCE-II, pending successful completion will submit for PMA approval.
ReCor Medical is a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd.
About Otsuka Medical Devices Co., Ltd.
Otsuka Medical Devices focuses on the global development and commercialization of endovascular devices that provide new therapeutic options in areas where patient needs cannot be met through pharmaceutical or other conventional treatment. Otsuka Medical Devices Co., Ltd. is a subsidiary of Otsuka Holdings Co., Ltd. (www.otsuka.com/en), a leading global healthcare group listed on the Tokyo Stock Exchange (JP 4578).
https://www.omd.otsuka.com/en/
For more information about ReCor Medical, please visit www.recormedical.com or contact Andrew M. Weiss, President & CEO, ReCor Medical at aweiss@recormedical.com / +1-650-542-7700.
