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Otsuka Receives Japanese Approval โfor Paradise Ultrasound System toโค Treatโ Resistant Hypertension
Published:โค August โค25, 2025
Source: world-today-news.com
Articleโ Section: Medical Devices, Cardiology
Backstory: Resistant hypertension, a condition โaffecting millions globally, poses a significant challenge โฃto healthcare systems. The Paradise ultrasound renal denervation system represents a perhaps groundbreaking non-pharmacological approach to managing this difficult-to-treat form ofโ high blood โpressure, offering hope to patients who haven’t responded to conventional therapies.
otsuka Medical Devices Co., โLtd. โคannounced โขtoday theโ receipt of manufacturing and โmarketing approvalโ in โขJapan for the โขParadiseโ ultrasound renal denervation (uRDN) system. this innovative system is designed to treat resistant hypertension – high blood pressure that remains uncontrolled despiteโ the use โofโ three or more different medications, including a diuretic.
The Paradise uRDN system was โขdeveloped by โRecor Medical, Inc., aโ U.S.-based subsidiary of โขOtsuka Medical Devices. the approval in โJapan is based onโค compelling โdata from the RADIANCE-HTNโ TRIO study, aโ rigorous randomized, sham-controlled clinical trial conducted across the United States and Europe.
Theโ RADIANCE-HTNโ TRIO study enrolled patientsโ alreadyโ receiving a standardized tripleโค antihypertensive therapy regimen.Results demonstrated a statistically significant andโ clinically meaningful reductionโค in daytime ambulatory โsystolic blood โคpressure atโฃ two months post-treatment with the Paradise โuRDN system. โImportantly, the system โexhibitedโ a consistently โขfavorable safety profileโ throughout the duration of the study.
Otsuka Medical Devices confirmed that a postmarketโ surveillance study willโค be conducted inโ Japan, adhering โคto โall local regulatory requirements. This ongoing monitoring will โprovide further insights into the โฃlong-term safetyโข and efficacy โof the Paradise system within the Japaneseโ population.
The paradiseโฃ uRDN system has already secured regulatory approvalsโ in key markets, including โฃthe United statesโข (FDA approval) and Europe โข(CEโข Mark approval). โTo ensure comprehensiveโ and long-term data collection, theโ GPS postmarket โregistry is actively enrolling patients in โthe European Union, United Kingdom, and United States, โwith plans for expansionโค to a โglobal scale.
“This approval marks a significant milestone in our commitment to providing innovative solutions โfor patients with resistant hypertension,” stated โฃa representativeโฃ from Otsuka Medical Devices.
“We โbelieve the Paradise system has the potential to transform the treatment landscape for this challenging condition.”
Renalโ denervation, the underlying โคprinciple of the Paradise system, involves using ultrasound โenergy to disrupt โคthe nerves surrounding the renal arteries. This disruption helps to โขregulate blood pressure by reducing sympathetic nervous system activity. Theโ Paradise system’s unique ultrasound-based approach aims to offer aโค precise and targetedโ treatment option.
Understanding Resistant Hypertension:โฃ Trends and Insights
Resistant hypertension is a growing โคglobal โhealth concern, frequently enough linked to factors like aging populations,โฃ increasing rates of obesity, and lifestyle factors. Current estimates suggestโข that 10-30% of hypertensive patientsโค experience resistanceโ to conventional therapies. The progress of novel treatment modalities,such asโ renalโข denervation,is crucial to address this unmet medical need.โค Future research will likely โขfocus on identifying ideal โฃpatientโข populations for uRDN and optimizing โtreatment protocols to maximize efficacy and long-term benefits.