Trending...
- AI Visibility: The Key to Beating Google's AI Overviews and Regaining Traffic
- New Mobile Car Detailing Platform Connects Drivers with On-Demand Local Pros
- Cal State LA secures funding for two artificial intelligence projects from CSU
PALO ALTO, Calif., May 16, 2021 /PRNewswire/ -- ReCor Medical, Inc. ("ReCor"), a wholly-owned subsidiary of Otsuka Medical Devices Co., Ltd., today presented the primary endpoint data from the randomized sham-controlled RADIANCE-HTN TRIO ("TRIO") study. In subjects with resistant hypertension, those treated with the Paradise™ Ultrasound Renal Denervation System had a greater drop in blood pressure than those who received a sham procedure. TRIO results were presented today at the American College of Cardiology meeting (https://accscientificsession.acc.org/) and published simultaneously in The Lancet.
The TRIO study evaluated the efficacy and safety of the Paradise Ultrasound Renal Denervation System in hypertensive patients who were all treated with a single pill containing 3 standardized anti-hypertension medications (a calcium-channel blocker, an angiotensin II receptor blocker, and a thiazide diuretic). After confirmation of inadequately controlled hypertension despite these medications, patients were then randomly assigned to treatment with the Paradise System or a sham procedure, with no changes to medications through two months.
The study met its primary efficacy endpoint at two months, demonstrating that patients who received Paradise renal denervation had a median reduction of 8.0 mmHg in daytime ambulatory systolic blood pressure, a 4.5 mmHg greater drop as compared with patients who had the sham procedure. Similar reductions were observed in 24-hour blood pressure, nighttime blood pressure, and office blood pressure. In addition, there were no significant differences in adverse events in the renal denervation and sham groups.
More on The Californer
"RADIANCE-HTN TRIO is the first study of its kind – a sham-controlled study where all patients were placed on a guideline-recommended regimen of three antihypertensive medications and then confirmed to have hypertension resistant to this regimen," commented co-principal investigator Ajay J. Kirtane, MD, SM, Professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons. "These data confirm the blood pressure-lowering effect of the Paradise Ultrasound Renal Denervation System in patients with resistant hypertension."
"RADIANCE-HTN TRIO had an extremely rigorous study design, executed over a number of years by dozens of committed study centers in the US and Europe," added co-principal investigator Professor Michel Azizi, MD, PhD, Professor of Medicine at Université de Paris, Head of the ESH Hypertension Excellence Center, Hôpital Européen Georges Pompidou, Paris, France. "By lowering blood pressure in resistant hypertensive patients, endovascular ultrasound renal denervation may become a valuable tool in the treatment of hypertension in this broad class of patients in need."
"ReCor is extremely pleased with the primary outcomes of the RADIANCE-HTN TRIO study, showing the positive treatment effect of the Paradise System," commented ReCor President & CEO, Andrew M. Weiss. "ReCor believes that TRIO is a seminal study with the potential to change medical practice for patients who are resistant to oral antihypertensive medications."
The Paradise System bears the CE mark in Europe and is an investigational device in the United States. The Paradise System is currently under investigation in the United States and Europe in the FDA IDE RADIANCE-HTN Clinical Study, and in the on-going FDA IDE pivotal study (RADIANCE-II) in patients with uncontrolled hypertension, with anticipated study completion of enrollment in 2021.
More on The Californer
Hypertension is the leading contributor 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. The Paradise System 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 randomized, sham-controlled studies of the Paradise System in patients with both moderate hypertension and those resistant to standard medical therapies. ReCor is currently conducting its FDA IDE pivotal study, RADIANCE-II, and pending successful completion will submit for PMA approval.
ReCor Medical is a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd.
http://www.recormedical.com/
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/
Contact: Andrew M. Weiss, [email protected]
SOURCE ReCor Medical, Inc.
Related Links
http://www.recormedical.com
The TRIO study evaluated the efficacy and safety of the Paradise Ultrasound Renal Denervation System in hypertensive patients who were all treated with a single pill containing 3 standardized anti-hypertension medications (a calcium-channel blocker, an angiotensin II receptor blocker, and a thiazide diuretic). After confirmation of inadequately controlled hypertension despite these medications, patients were then randomly assigned to treatment with the Paradise System or a sham procedure, with no changes to medications through two months.
The study met its primary efficacy endpoint at two months, demonstrating that patients who received Paradise renal denervation had a median reduction of 8.0 mmHg in daytime ambulatory systolic blood pressure, a 4.5 mmHg greater drop as compared with patients who had the sham procedure. Similar reductions were observed in 24-hour blood pressure, nighttime blood pressure, and office blood pressure. In addition, there were no significant differences in adverse events in the renal denervation and sham groups.
More on The Californer
- Swim Up Hill Consulting Secures New City Contracts, Expands National & Global Reach Ahead of LA28
- Fastest Growing Staffings Firms
- Inframark Continues to Build Its Community Management Capabilities and Multi-Disciplinary Presence in Arizona
- ICAST 2025: The Crystal-Clear Revolution Begins at Booth #3233
- Rachel Farris, CPA Featured on The AJ Brown Show to Discuss Act 60 Tax Incentives
"RADIANCE-HTN TRIO is the first study of its kind – a sham-controlled study where all patients were placed on a guideline-recommended regimen of three antihypertensive medications and then confirmed to have hypertension resistant to this regimen," commented co-principal investigator Ajay J. Kirtane, MD, SM, Professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons. "These data confirm the blood pressure-lowering effect of the Paradise Ultrasound Renal Denervation System in patients with resistant hypertension."
"RADIANCE-HTN TRIO had an extremely rigorous study design, executed over a number of years by dozens of committed study centers in the US and Europe," added co-principal investigator Professor Michel Azizi, MD, PhD, Professor of Medicine at Université de Paris, Head of the ESH Hypertension Excellence Center, Hôpital Européen Georges Pompidou, Paris, France. "By lowering blood pressure in resistant hypertensive patients, endovascular ultrasound renal denervation may become a valuable tool in the treatment of hypertension in this broad class of patients in need."
"ReCor is extremely pleased with the primary outcomes of the RADIANCE-HTN TRIO study, showing the positive treatment effect of the Paradise System," commented ReCor President & CEO, Andrew M. Weiss. "ReCor believes that TRIO is a seminal study with the potential to change medical practice for patients who are resistant to oral antihypertensive medications."
The Paradise System bears the CE mark in Europe and is an investigational device in the United States. The Paradise System is currently under investigation in the United States and Europe in the FDA IDE RADIANCE-HTN Clinical Study, and in the on-going FDA IDE pivotal study (RADIANCE-II) in patients with uncontrolled hypertension, with anticipated study completion of enrollment in 2021.
More on The Californer
- Brindle Pet Supplies Now Carries Badlands Ranch Dog Food in Canada
- Jade & Zelda Launch Virtually Human: A Groundbreaking Podcast Hosted by AI-Powered Virtual Humans
- Dr. Satyam Priyadarshy Joins Indemnify AI to Enrich AI Risk Financial Quantification
- $10 Million Allocated to Establish Crypto Treasury Focused on High Value Ethereum (ETH) & Bitcoin (BTC) as Long-Term Holdings for Cybersecurity Leader
- Fact: Trump lied — again. California gas prices remain lower than a week ago, month ago, and a year ago
Hypertension is the leading contributor 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. The Paradise System 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 randomized, sham-controlled studies of the Paradise System in patients with both moderate hypertension and those resistant to standard medical therapies. ReCor is currently conducting its FDA IDE pivotal study, RADIANCE-II, and pending successful completion will submit for PMA approval.
ReCor Medical is a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd.
http://www.recormedical.com/
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/
Contact: Andrew M. Weiss, [email protected]
SOURCE ReCor Medical, Inc.
Related Links
http://www.recormedical.com
Filed Under: Business
0 Comments
Latest on The Californer
- 24/7 customizable AI answering service from Kell Web Solutions, Inc. helps businesses never miss a customer call, lead, or appointment again
- TikTok Star ArcadeFriends Attempts 24-Hour Claw Machine Marathon at Lucky Puppy Arcade in Las Vegas
- Revolutionary conversational AI transforms customer engagement with professional virtual receptionist answering service tailored for small busines
- New AI platform helps small businesses deliver always-available, professional customer service without added staff or complexity
- VoiceGenie AI empowers small businesses with 24/7, brand-driven customer engagement through an AI-powered virtual front desk receptionist
- California: Governor Newsom signs tribal-state gaming compact 7.14.25
- VoiceGenie AI empowers small businesses with human-like call answering and customer engagement—bridging the gap between automation and live
- New 24/7 AI solution transforms customer engagement and efficiency for small businesses seeking live virtual receptionist services
- Next-generation virtual receptionist service leverages AI to ensure every customer call and text is answered, enhancing efficiency and engagem
- Next-Gen AI Receptionist Elevates Customer Communication, Boosts Efficiency for Small Businesses
- California: Governor Newsom signs legislation 7.14.25
- New AI-Powered Platform from Kell Web Solutions Delivers 24/7 Professional, Automated Call Handling and Appointment Scheduling
- Kell Web Solutions Launches Next-Gen VoiceGenie AI Call Answering Service for Businesses
- 24/7 Conversational AI Platform Raises the Standard for Small Business Customer Engagement
- Pyro Marketing Launches New Website to Accelerate Growth for Fitness Brands
- QuickLogic Announces the Passing of Board Director Christine Russell
- KCON LA 2025, 106.3 RAIN FM 'Take Over' Special Event
- IEI USA Launches SHIELD Rugged Stainless Steel Panel PCs for Hygiene-Critical Industries
- In historic first, California powered by two-thirds clean energy – becoming largest economy in the world to achieve milestone
- North Island Credit Union Foundation Provides $5,000 in Teacher Grants To Benefit Educators & Students