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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.
Frequently Asked Questions about the Paradise Ultrasound System
| Question | Answer |
|---|---|
| What is resistant โขhypertension? | Resistant hypertension is high blood pressureโค that remains uncontrolledโฃ despiteโฃ takingโฃ three or more different types of blood pressure medication, including a diuretic. |
| How does the Paradise system work? | The Paradise system โขusesโ ultrasoundโฃ energy to disrupt theโฃ nerves around the renal arteries, reducingโ sympathetic nervous system activity and lowering bloodโข pressure. |
What โคwere the keyโ findings
Coronary Sinus Reduction: New Analysis Suggests Modest Benefits for Refractory AnginaA novel approach to treating severe chest pain – coronary sinus reduction (CSR) using an hourglass-shaped stent – is facing renewed scrutiny. While initial studies hinted at significant relief for patients with refractory angina (chest pain that doesn’t respond to conventional treatments), a new meta-analysis published in JACC: Cardiovascular Interventions suggests the benefits may be less substantial than previously thought. The analysis, led by Dr. rasha Al-Lamee of Imperial College London,pooled data from three randomized controlled trials encompassing 180 patients,alongside 13 single-arm studies involving 668 individuals. The procedure itself appears safe, boasting a 98.3% success rate. However, a key finding reveals a stark contrast between the results of rigorously controlled trials and earlier, less controlled studies. Patients did report improvements in angina symptoms in both types of studies. however,the magnitude of improvement was considerably smaller in the randomized controlled trials. Specifically, approximately 26% of patients in the controlled trials experienced at least a one-class improvement in angina severity (according to the Canadian Cardiovascular Society classification), while 17% saw at least a two-class improvement. These figures represent roughly a third of the gains observed in the single-arm studies. Crucially, the controlled trials failed to demonstrate any objective benefits. Continuous measurements like the Seattle Angina questionnaire showed no significant change, and there was no evidence of improved blood flow to the heart muscle following the procedure. Dr. Deepak Bhatt, a cardiologist at Mount Sinai in New York City, who penned an accompanying editorial, emphasized the need for more effective treatments for refractory angina patients, who have often fatigued all other options. While CSR holds potential, he cautioned that larger, more definitive trials are essential before widespread adoption. “We need robust,objectively measured evidence to justify the cost of this procedure,” he stated. He pointed to past examples, like percutaneous laser therapy, which initially appeared promising but ultimately proved ineffective in rigorous trials. Currently approved for use in the UK and Europe, where its adoption is growing, the CSR device is not yet available in the United States. The ongoing COSIRA-II trial, enrolling approximately 380 patients, is expected to provide the conclusive data needed for potential US approval. Dr. Al-Lamee believes that if COSIRA-II demonstrates clear benefits, the device coudl become a preferred treatment option before more invasive procedures like repeat coronary artery bypass surgery. “Why resort to a high-risk revascularization if a safe and effective option exists?” she proposed. Dr. Al-Lamee disclosed financial ties to Shockwave Medical, the manufacturer of the CSR device. Dr. Bhatt reported no relevant financial conflicts. 
Heart Attack Deaths Plummet 90% in U.S., But Chronic Heart Disease is SurgingTable of Contents Published: November 8, 2024 at 10:00 AM PST By Dr. Michael Lee, World-Today-News.com Washington D.C. – A groundbreaking new study reveals a dramatic 90% decrease in deaths from heart attacks in the United States since 1970, marking a monumental public health achievement. However, this victory is tempered by a concerning rise in deaths from other cardiovascular conditions, signaling a shift in the landscape of heart disease. The research, published recently, attributes the decline in acute heart attack fatalities to decades of concerted efforts, including robust anti-smoking campaigns, advancements in emergency medical care, the widespread adoption of statin medications and stent procedures, and a heightened focus on rapid heart attack diagnosis and treatment. These interventions have demonstrably improved immediate survival rates. Despite this progress,deaths related to arrhythmias have surged by over 400% as 1970. Fatalities stemming from heart failure have increased by nearly 150%,and heart disease linked to hypertension has doubled during the same period. experts attribute this trend to a growing emphasis on acute care while chronic disease management remains under-prioritized. “We’ve become exceptionally skilled at rescuing individuals during a heart attack, but we are falling short in addressing the underlying chronic conditions that contribute to long-term cardiovascular health,” explains Dr. Dmitry Yaranov, an advanced heart failure cardiologist. “An aging population, coupled with the increasing prevalence of obesity, diabetes, and hypertension, is driving this shift. Long-term health requires sustained attention and access to care.” The study underscores that while fewer people are succumbing to immediate heart attacks, a larger number are living with chronic cardiovascular diseases, ultimately leading to delayed mortality. This highlights the critical need for a paradigm shift towards proactive, lifelong prevention strategies. The focus must extend beyond immediate intervention to encompass complete chronic disease management, including lifestyle modifications, regular monitoring, and personalized treatment plans. Addressing these factors is crucial to reversing the rising tide of chronic heart disease and ensuring sustained improvements in cardiovascular health. Understanding the Evolution of Heart DiseaseCardiovascular disease has been the leading cause of death globally for decades. Historically, acute events like heart attacks were the primary drivers of mortality. However, advancements in medical technology and public health initiatives have significantly reduced the risk of dying from a heart attack in the immediate aftermath. This success story is built upon decades of research into risk factors,such as smoking,high cholesterol,and high blood pressure. The rise in chronic heart conditions reflects a broader trend of increasing longevity and lifestyle-related diseases. As populations age, the cumulative effects of chronic conditions become more pronounced. Factors like obesity, diabetes, and sedentary lifestyles contribute to the development of heart failure, arrhythmias, and hypertension. These conditions often develop over years or decades, making early detection and proactive management essential. Moreover, the increasing prevalence of these chronic conditions places a significant strain on healthcare systems. Effective management requires a multi-faceted approach, including preventative measures, early diagnosis, and ongoing care. Investment in public health initiatives, research, and access to affordable healthcare are crucial to addressing this growing challenge. Frequently Asked Questions About Heart Disease Trends
Here’s a rewritten version of the article, aiming for 100% uniqueness while preserving all verifiable facts: Navigating Research Hurdles: Medical Students Face Funding Challenges Medical students seeking research experience are encountering a more competitive landscape due too important cuts in funding, a situation that could possibly disadvantage even highly capable individuals. As Dr. bobby Mukkamala notes, “some really grate students may be sort of left behind.” While some students may opt for international research collaborations, Mukkamala points out the ample financial burden this adds to the already considerable cost of medical school. He highlights the practical difficulties: “trying to figure out how am I going to get to Germany, as in this example, to collaborate with people whose funding isn’t threatened on the exact same topic that I could have done here in my backyard.” Guidance for Aspiring Medical Researchers Dr. Naidu emphasizes that research remains a highly valuable endeavor for medical students. He states it’s beneficial “both in terms of helping you get to the next stage of your career, but also in and of itself, because it might stimulate you to go into a field of research, (in) a fabulous field that can allow you to be part of scientific progress in the world.” Though, with diminishing funding opportunities, naidu advises students to broaden their search and consider research topics they might not have initially explored.To address this, Naidu has established the Medical Research Fund at Brown University School of Medicine, his alma mater, which provides summer research stipends for three medical students annually. Mukkamala suggests that students inquire about the grant funding status of laboratories they are interested in during interviews. He acknowledges the increased difficulty: “There’s less opportunities, but the best and the brightest will be able to find opportunities to still do research andโฆlearn about the process and be competitive to move on in their careers. But it’s going to be a little harder because overall there’ll be less opportunities in total.” Naidu expresses concern about the current trend, stating, “This is a time in history we’re making major cuts to something that has been sustainable for a long time,” and warns that these cuts could set research funding back by “30 years.” Fourth-year medical student Alisch,who experienced delays during his research year at the NIH,is adopting a patient approach. Despite the setbacks, he remains optimistic about his future in medical science research. Alisch observes, “We are only about 6-7 months into this. We have a lot more time to go through before we can see how this is actually going to play out.” 
Cardiac PTSD: New Strategies Emerge to Aid RecoveryInnovative approaches aim to mitigate trauma after life-altering cardiac events.For those who survive major heart incidents, the ordeal doesn’t always end with physical recovery; many grapple with cardiac post-traumatic stress disorder (PTSD). Researchers are now developing new interventions to help patients avoid or escape this cycle. Understanding Cardiac PTSDFor almost fifteen years, Donald Edmondson, PhD, at Columbia University Irving Medical Center, has focused on cardiac PTSD. His work highlights that a significant portionโup to one-thirdโof individuals develop this condition after major cardiac events. James Jackson, PsyD, at Vanderbilt University, was among the first to specifically address cardiac PTSD. He noted the scarcity of support programs for cardiovascular ICU survivors, unlike those available for cancer survivors. 
Simple Screening SystemAccording to Edmondson, interventions could begin with a straightforward four-point screening system integrated into routine cardiology follow-ups. This would involve identifying patients who were significantly frightened by their cardiac event. Additional indicators include patients who frequently discuss their cardiac sensations, report sleep disturbances, or have reduced physical activity. These factors can collectively signal a higher risk of developing cardiac PTSD, according to research findings. If a patient is deemed high risk, Edmondson suggests referral to a behavioral health professional. Exposure therapy may be considered, alongside other therapeutic approaches, depending on the patientโs specific symptoms. Edmondson also noted that the existing depression care model in cardiology could be expanded. Preliminary data suggests bringing behavioral health into cardiology clinics could reduce cardiac risk and improve health behaviors for recent cardiac event survivors. The Role of Compassion and TechA 2019 study by Jeena Moss, MD, found that clinician compassion and a less stressful medical experience can disrupt the cycle of cardiac PTSD. However, standardizing these elements remains a challenge. Interestingly, a 2018 study co-authored by Edmondson revealed a placebo-like effect from percutaneous coronary intervention (PCI) and stent placement. He believes some patients incorrectly feel “cured” by these procedures, embracing a Tech-Driven InterventionsJeffrey L. Birk, PhD, MS, at Columbia University, is exploring technology-based interventions to address patientsโ fears of recurrent cardiac events. His work focuses on internal triggers like increased heart rate and perceived arrhythmias that can be misinterpreted as dangerous.  Birk aims to develop systems that can dynamically assess these processes in real-time, understanding when and how interoceptive attention affects patients’ well-being. Similarly, Sachin Agarwal, MD, MPH, is investigating how AI-powered models can offer personalized support, improve follow-up, and broaden family-centered interventions. According to the CDC, about 1 in 5 heart attack survivors experience depression, highlighting the need for comprehensive mental health support.
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