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Recor's Paradise Renal Denervation System
Gets FDA Approval
The Paradise Ultrasound Renal Denervation (RDN) System is the First and Only Device Approved for Use in the U.S.
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The Recor Paradise Renal Denervation System |
November 13, 2023 -- Last week the FDA approved the first renal denervation (RDN) system ever for use in
the United States. The Paradise system is manufactured by Recor Medical, headquartered in Palo Alto, California; the company is a wholly-owned subsidiary of Japan-based Otsuka Medical Devices Co., Ltd. The Paradise RDN system had been approved for the CE Mark in Europe over a decade ago, as have several other systems from Medtronic, et al, but this is the first system that has received approval to be marketed in the U.S.
Elevated blood pressure, or hypertension, is a major health issue. Studies have shown that hypertension is associated with increased heart disease, dementia, and other health issues. So keeping blood pressure within the guidelines is important. While there are several medications that help control elevated blood pressure, some patients are resistant to these, or are not able to adhere to the regimen of multiple medications. It is these patients that may be helped by renal denervation.
Renal denervation is basically an interventional procedure, not unlike angioplasty, where a catheter, that is inserted via the femoral artery in the groin, or the radial artery in the wrist, is advanced to the renal arteries which supply the kidney. These arteries have been found to control blood pressure and disabling, or denervating, them has a beneficial effect on hypertension.
All the device manufacturers in this field have conducted randomized controlled trials to show benefit; most have performed "sham" or placebo-controlled studies to show that RDN does in fact have a meaningful effect for those patients who are resistent to medical therapy. But to date, the Paradise system is the only one that the FDA has felt has proven that hypothesis.
So, with this approval some have opined that RDN therapy is now a "game-changer," that it is going to radically change the treatment of hypertension, and that it may in fact "cure" hypertension. Dr. Ajay Kirtane, Director of the Columbia Interventional Cardiovascular Care program and Professor of Medicine at the Columbia University Irving Medical Center, who has been the principal investigator for the Paradise system, told Angioplasty.Org how he views this term:
Dr. Ajay Kirtane |
"I have a saying that the word 'game-changer' is the most overused word that could exist...the reality is there very few things are actually that way. Now, I will say that in a sense, having a device-based technology that is agnostic to adherence, it changes the game.
But the magnitude of the change is something that we have to be very, very circumspect about. It gives us another option. It opens another dimension. But let's not say that this is going to cure hypertension.
This is going to be an adjunct to everything we already do."
The press release from Recor Medical follows:
Recor Medical and Otsuka Medical Devices Announce First FDA-Approved Renal Denervation System for the Treatment of Hypertension
Approval of the Paradise™ Ultrasound Renal Denervation system makes innovative hypertension treatment available for the first time in the U.S.
November 7, 2023 -- Palo Alto, California -- Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today announced the U.S. Food and Drug Administration (FDA) has approved Recor’s Paradise™ Ultrasound Renal Denervation (RDN) system for the treatment of hypertension.
The Paradise system is intended as an adjunctive treatment option when lifestyle changes and medications have not adequately controlled a patient’s blood pressure. It is a first-of-its-kind ultrasound-based RDN technology designed to lower blood pressure by denervating the sympathetic nerves surrounding the renal arteries, reducing the overactivity that can lead to hypertension. The Paradise system delivers two to three doses of 360-degree ultrasound energy — lasting seven seconds each — through each of the main renal arteries to the surrounding nerves. The Paradise catheter features the exclusive HydroCooling™ system, which circulates sterile water through the balloon catheter during the procedure to help protect the renal artery wall.
Approval of the Paradise system follows Recor’s positive FDA Advisory Committee Panel in August 2023. Earlier this year, results from Recor’s US pivotal study, the RADIANCE™ II Randomized Clinical Trial, were published in the Journal of the American Medical Association (JAMA). In the study, the Paradise Ultrasound RDN system met both the primary safety and effectiveness endpoints without any major adverse events.
“Recor is leading the way in bringing an innovative solution to clinicians and their patients struggling to control blood pressure. This FDA approval is the culmination of years of technical research and rigorous clinical studies,” said Lara Barghout, President and CEO of Recor Medical. “We are grateful to the patients who participated in the studies and to the clinical trial investigator teams whose diligence and dedication made FDA approval possible. We look forward to making this technology available to physicians and their patients nationwide.”
Recor has been focused on developing and testing the Paradise Ultrasound RDN system for the treatment of hypertension since 2009. The RADIANCE global program studied the Paradise system in three independently powered, sham-controlled, randomized clinical trials in over 500 patients with uncontrolled hypertension: RADIANCE II and RADIANCE-HTN SOLO, which studied patients with mild-moderate hypertension in an “off-meds” setting, and RADIANCE-HTN TRIO, which studied patients with resistant hypertension on standardized triple antihypertensive therapy. Each trial met its prescribed primary efficacy endpoint with a favorable safety profile consistently observed following ultrasound RDN treatment.
“Despite the longstanding availability of dozens of affordable anti-hypertensive medications, blood pressure control rates in the United States are alarmingly low and falling. Given the significant blood pressure reductions seen in the ultrasound renal denervation trials, the Paradise Ultrasound Renal Denervation system offers a much-needed advancement in our currently available options to control hypertension,” said site principal investigator Naomi Fisher, MD, Associate Professor of Medicine, Harvard Medical School, and Director of Hypertension Service and Hypertension Innovation, Division of Endocrinology, Diabetes and Hypertension at Brigham and Women’s Hospital. “uRDN has proven efficacy in patients with truly resistant hypertension, a population for whom medication therapy often fails. It is also effective in patients with mild to moderate hypertension who cannot tolerate enough medication to control their blood pressure.”
“Approval of the Paradise Ultrasound RDN system marks an important milestone for the company and provides a new adjunctive treatment option for hypertension which remains inadequately controlled despite conventional therapies,” said Noriko Tojo, President and Representative Director of Otsuka Medical Devices and Executive Director of Otsuka Holdings Co., Ltd. “We are excited for patients and their healthcare professionals to have access to this technology to assist in managing hypertension and improving outcomes.”
Hypertension is the leading contributor to disease burden worldwide, resulting in increased cardiovascular morbidity and mortality, poor quality of life, and higher costs to health systems. The Paradise Ultrasound RDN system previously received CE mark and has been successfully introduced in Europe and is an investigational device in Japan.
About Recor Medical, Inc.
Recor 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 system for the treatment of hypertension. The Paradise system is an investigational device in Japan, is FDA approved in the United States, and bears the CE mark. 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. In addition, Recor has begun the Global Paradise System (“GPS”) Registry in the EU, with plans to expand globally.
About Otsuka Medical Devices Co., Ltd.
Otsuka 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., a global healthcare company listed on the Tokyo Stock Exchange (JP 4578).
Reported by Burt Cohen, November 13, 2023
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