{"id":46556,"date":"2022-07-26T10:01:41","date_gmt":"2022-07-26T08:01:41","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/recor-medical-and-otsuka-medical-devices-announce-primary-endpoint-met-in-the-radiance-ii-us-pivotal-trial-of-the-paradise-system-for-the-treatment-of-hypertension\/"},"modified":"2022-07-26T10:01:41","modified_gmt":"2022-07-26T08:01:41","slug":"recor-medical-and-otsuka-medical-devices-announce-primary-endpoint-met-in-the-radiance-ii-us-pivotal-trial-of-the-paradise-system-for-the-treatment-of-hypertension","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/recor-medical-and-otsuka-medical-devices-announce-primary-endpoint-met-in-the-radiance-ii-us-pivotal-trial-of-the-paradise-system-for-the-treatment-of-hypertension\/","title":{"rendered":"ReCor Medical and Otsuka Medical Devices Announce Primary Endpoint Met in the RADIANCE II US Pivotal Trial of the Paradise\u2122 System for the Treatment of Hypertension"},"content":{"rendered":"
\n

PALO ALTO, Calif.–(BUSINESS WIRE)–ReCor Medical, Inc. (\u201cReCor\u201d) and Otsuka Medical Devices Co., Ltd., a fully owned subsidiary of Otsuka Holdings Co., Ltd., today announced that the RADIANCE II US FDA IDE pivotal trial evaluating the Paradise\u2122 Ultrasound Renal Denervation (uRDN) System as a treatment for hypertension met its primary efficacy endpoint, demonstrating a statistically significant reduction in daytime ambulatory systolic blood pressure between treatment and a sham procedure measured at two months.\n<\/p>\n

<\/a><\/p>\n

\nThe RADIANCE II US FDA IDE pivotal trial is a randomized, sham-controlled clinical trial of the ReCor Paradise uRDN System for the treatment of patients with uncontrolled hypertension. 224 patients with mild-to-moderate uncontrolled hypertension, previously treated with up to two medications, were randomized while off medications at more than 60 study centers in 8 countries.\n<\/p>\n

\n\u201cDespite the truly formidable challenges of conducting a complex clinical trial in the throes of the COVID-19 pandemic, we are thrilled to observe these positive results of RADIANCE II, especially in light of those we have previously reported from RADIANCE-HTN SOLO and TRIO,\u201d said Study Principal Investigators Ajay Kirtane, Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons \/ NewYork-Presbyterian Hospital and Michel Azizi, Professor of Medicine at Universit\u00e9 Paris Cit\u00e9, H\u00f4pital Europ\u00e9en Georges Pompidou, Paris, France. \u201cWe cannot adequately convey our thanks to the patients, coordinators, and study physicians for their collective efforts, and we very much look forward to being able to present and publish the complete study details in the near future.\u201d\n<\/p>\n

\n\u201cWe at Otsuka are very pleased with the positive outcome of the RADIANCE II study,\u201d said Kazumichi Kobayashi, Executive Deputy President of Otsuka Medical Devices. \u201cWith three successful clinical trials of the Paradise uRDN System, we believe even more strongly that the Paradise System can become an important treatment option for patients and physicians struggling to control blood pressure.\u201d\n<\/p>\n

\n\u201cReCor is thrilled that the RADIANCE II trial met its primary efficacy endpoint. Following the positive SOLO and TRIO clinical trials, RADIANCE II adds to the evidence for the Paradise System as a potential future treatment for patients with uncontrolled hypertension,\u201d said ReCor president and CEO, Andrew M. Weiss. \u201cWe would like to express our gratitude to the Principal Investigators, Steering Committee and all investigators for their efforts throughout this important trial.\u201d\n<\/p>\n

\nRADIANCE II is the third and largest component of ReCor\u2019s RADIANCE Global Program\u2014randomized and sham-controlled studies evaluating the Paradise uRDN System in patients with hypertension. The first two studies in the series are the previously reported RADIANCE-HTN SOLO (conducted in patients with mild-to-moderate hypertension) and TRIO (conducted in those who remained hypertensive despite being on antihypertensive therapy). Both studies met their primary effectiveness endpoints. With RADIANCE II, ReCor now has a third positive trial, with more than 500 patients randomized in the RADIANCE Global Program. ReCor has also begun the Global Paradise System (\u201cGPS\u201d) Registry\u2014a real-world study of up to 3,000 patients with uncontrolled hypertension.\n<\/p>\n

\nAbout ReCor Medical, Inc.<\/b>\n<\/p>\n

\nReCor Medical, headquartered in Palo Alto, CA, a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd., is a medical technology company focused on transforming the management of hypertension. ReCor has pioneered the use of the Paradise ultrasound renal denervation (uRDN) system for the treatment of hypertension. The Paradise System is an investigational device in the United States and bears the CE mark in the EU. ReCor has reported positive outcomes in three independent, randomized, sham-controlled studies of the Paradise System in patients with mild-to-moderate and resistant hypertension and plans to submit results of its RADIANCE Global Program as part of a PMA to the US FDA for market approval. In addition, ReCor has initiated the Global Paradise System (\u201cGPS\u201d) Registry in the EU with plans to expand on a global basis.\n<\/p>\n

\nhttp:\/\/www.recormedical.com\/<\/a>\n<\/p>\n

\nAbout Otsuka Medical Devices Co., Ltd.<\/b>\n<\/p>\n

\nOtsuka Medical Devices focuses on the global development and commercialization of medical care products including 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>), a global healthcare company listed on the Tokyo Stock Exchange (JP 4578).\n<\/p>\n

\nhttps:\/\/www.omd.otsuka.com\/en\/<\/a>\n<\/p>\n

Contacts<\/b> <\/p>\n

\nAnnika Parrish
\n
Health+Commerce
\n
annika@healthandcommerce.com<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

PALO ALTO, Calif.–(BUSINESS WIRE)–ReCor Medical, Inc. (\u201cReCor\u201d) and Otsuka Medical Devices Co., Ltd., a fully owned subsidiary of Otsuka Holdings Co., Ltd., today announced that the RADIANCE II US FDA IDE pivotal trial evaluating the Paradise\u2122 Ultrasound Renal Denervation (uRDN) System as a treatment for hypertension met its primary efficacy endpoint, demonstrating a statistically significant … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-46556","6":"format-standard","7":"category-industry"},"yoast_head":"\nReCor Medical and Otsuka Medical Devices Announce Primary Endpoint Met in the RADIANCE II US Pivotal Trial of the Paradise\u2122 System for the Treatment of Hypertension - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/recor-medical-and-otsuka-medical-devices-announce-primary-endpoint-met-in-the-radiance-ii-us-pivotal-trial-of-the-paradise-system-for-the-treatment-of-hypertension\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ReCor Medical and Otsuka Medical Devices Announce Primary Endpoint Met in the RADIANCE II US Pivotal Trial of the Paradise\u2122 System for the Treatment of Hypertension - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"PALO ALTO, Calif.–(BUSINESS WIRE)–ReCor Medical, Inc. 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