Innovative Renal Denervation System Gains Approval in Japan
Revolutionizing Hypertension Treatment with Renal Denervation
Recor Medical, Inc. has made remarkable advancements in the treatment of resistant hypertension with the approved Paradise™ Ultrasound Renal Denervation (uRDN) system. This innovative technology recently received its manufacturing and marketing permit in Japan, providing a fresh avenue for patients suffering from this challenging condition. What makes this situation even more historical is that it's the first medical device approved in Japan specifically targeting resistant hypertension.
Groundbreaking Study Results
The approval of the Paradise uRDN system is underpinned by the successful outcomes of the RADIANCE-HTN TRIO study. Conducted across the U.S. and Europe, this randomized, sham-controlled trial was aimed at evaluating the efficacy of the Paradise system in patients undergoing a standardized triple antihypertensive therapy regimen that included a diuretic. The results were compelling, showing a substantial reduction in daytime ambulatory systolic blood pressure at two months after randomization, confirming the system's primary efficacy endpoints. Additionally, the safety profile throughout the study was highly favorable, indicating the device's reliability.
How the Paradise System Works
The Paradise uRDN system is uniquely designed to tackle hypertension via a novel ultrasound-based method. This system aims to reduce high blood pressure by disrupting the sympathetic nerves surrounding the renal arteries, which are often overactive in those with hypertension. It administers two to three doses of 360-degree ultrasound energy—lasting approximately seven seconds each—directly to the main renal arteries, targeting the nerves effectively. Notably, the system features an innovative HydroCooling™ mechanism to protect the renal arterial wall during the procedure, ensuring patient safety and comfort.
Expert Insights on Hypertension
Experts in the field emphasize the critical battle against resistant hypertension. Kazuomi Kario, President of the Japanese Society of Hypertension and Professor of Cardiovascular Medicine at Jichi Medical University, stated, “Resistant hypertension is a particularly high-risk form of high blood pressure that is challenging to manage effectively. The Paradise uRDN system emerges as a promising solution for these patients. Collaborative efforts involving key medical societies in Japan are focused on enhancing awareness of this condition and promoting available treatment options, ensuring patients receive the care they need.”
The Broader Impact
The gravity of hypertension as a leading cause of cardiovascular diseases—ranked among the top causes of mortality in Japan—cannot be overstated. Yoshio Kobayashi, President of the Japanese Circulation Society, noted that “the introduction of the Paradise uRDN system could significantly improve treatment outcomes and play a pivotal role in preventing cardiovascular incidents in the population.”
Minimally Invasive Interventions
As a component of proactive cardiovascular care, catheter-based interventions like the Paradise system are instrumental in providing minimally invasive treatment options. Ken Kozuma, President of the Japanese Association of Cardiovascular Intervention and Therapeutics, remarked on how the recognition of the uRDN system as a viable treatment for resistant hypertension marks a significant milestone in cardiovascular care. This device offers patients a non-invasive alternative for managing their condition, which can otherwise have severe health implications.
Future Directions for Recor Medical
Lara Barghout, President and CEO of Recor Medical, expressed optimism about the device's potential impact, stating, “We are thrilled that the Paradise uRDN system holds the distinction of being the first renal denervation device approved in Japan, marking a significant advancement in treatment options available to patients. Our mission is to expand access to this transformative therapy, enhancing both health outcomes and quality of life.” Recently, the Paradise system, after obtaining FDA approval in the U.S. in late 2023, has already been positively received among patients and healthcare providers alike, paving the way for a successful launch in Japan.
Commitment to Global Health
The commitment to elevating medical standards and improving patient outcomes doesn't stop at Japan. The Paradise uRDN system's journey continues with ongoing initiatives such as the Global Paradise System (GPS) post-market registry in the EU and UK, coupled with a post-approval study in the U.S. For Japan, a post-marketing surveillance study will ensure compliance with local regulations, embracing a patient-centered approach throughout its implementation.
Frequently Asked Questions
What is the Paradise uRDN system?
The Paradise uRDN system is a novel ultrasound-based device designed to treat resistant hypertension by disrupting the sympathetic nerves around renal arteries.
What recent approval did Recor Medical receive?
Recor Medical received approval for the Paradise uRDN system’s manufacturing and marketing in Japan, making it a unique solution for hypertension treatment.
How does the Paradise system work?
The system employs ultrasound energy to denervate sympathetic nerves surrounding the renal arteries, effectively lowering blood pressure levels.
What are the potential benefits of the Paradise uRDN system?
It provides a minimally invasive treatment option for resistant hypertension, which may lead to improved patient outcomes and quality of life.
What are the future plans for the Paradise uRDN system?
Beyond its introduction in Japan, ongoing studies and registries will support the collection of long-term data on the device's effectiveness and safety.
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