Breakthrough in Hypertension Treatment: Recor Medical's Results
Introduction to the Paradise Ultrasound Renal Denervation System
Recor Medical, Inc., together with its parent company Otsuka Medical Devices Co., Ltd., has recently presented exciting clinical findings regarding their innovative Paradise Ultrasound Renal Denervation (uRDN) system. These findings were shared at an important cardiology conference, emphasizing the significant impact the device has on patients struggling with resistant hypertension.
Significant Blood Pressure Reductions Demonstrated
The Global Paradise System (GPS) Registry has revealed a remarkable average reduction of 19.6 mmHg in office systolic blood pressure after just six months of using the Paradise uRDN system. This impressive data was primarily derived from a first-of-its-kind analysis of 212 patients, thanks to the dedicated efforts of medical professionals such as Dr. Karl Fengler from the Heart Center in Leipzig.
Understanding the GPS Registry Findings
The GPS Registry is a comprehensive registry that tracks various patients undergoing treatment with the Paradise uRDN system across nine nations. This unique study combined both prospective and retrospective data, all aimed at gauging the long-term effectiveness of the device while adhering to prescribed treatment guidelines. Notably, patients in this registry showcased higher baseline blood pressures compared to those in other studies, yet the procedure was completed safely, with no significant issues reported.
Long-Term Results from the RADIANCE Trials
Adding to the wealth of information available, the RADIANCE pooled analysis, which encompassed data from three major clinical trials, revealed a sustained decrease of 15.7 mmHg in office systolic blood pressure at a follow-up period of 24 months. This analysis included 243 patients and demonstrated that the benefits of the Paradise uRDN system are not only immediate but also durable over time.
Key Insights from Clinical Experts
Medical professionals involved in these studies, including Dr. Ajay J. Kirtane from Columbia University, expressed optimism about the potential of the Paradise uRDN system. They highlighted that the substantial reductions in blood pressure could translate into a reduced risk of cardiovascular diseases for patients, reinforcing the system's clinical significance.
The Mechanism Behind Paradise uRDN
The technology behind the Paradise uRDN system is revolutionary. It employs ultrasound waves to target and denervate sympathetic nerves surrounding the renal arteries, effectively curtailing the nerve overactivity that contributes to hypertension. During the procedure, ultrasound energy is delivered in carefully controlled doses ensuring safety and efficacy.
Benefits of the HydroCooling™ Technology
A standout feature of the Paradise uRDN system is its HydroCooling™ technology, which protects arterial walls during treatment by circulating sterile water through the balloon catheter. This advancement not only enhances patient comfort but also maintains the integrity of the renal arteries during the process.
Availability and Future Prospects
As of now, the Paradise uRDN system has received FDA approval and is available for use by patients in the United States. With its CE mark, it is also recognized in markets where such certification holds value, including parts of Europe and Japan. The device is tailored for patients who have not responded to conventional lifestyle modifications or antihypertensive medications.
The Vision of Recor Medical
Recor Medical is committed to reshaping the landscape of hypertension treatment through continual innovation and clinical excellence. The encouraging results generated from ongoing studies like the GPS Registry reflect the organization's dedication to advancing the understanding and management of treatment-resistant hypertension.
Frequently Asked Questions
What is the Paradise uRDN system?
The Paradise uRDN system is a novel device designed to lower blood pressure by denervating sympathetic nerves around the renal arteries using ultrasound technology.
How effective is the Paradise uRDN system?
The latest studies show an average reduction of 19.6 mmHg in office systolic blood pressure after six months and a sustained reduction of 15.7 mmHg after two years.
Who can benefit from the Paradise uRDN system?
This system is primarily designed for patients experiencing resistant hypertension who have not found relief through lifestyle changes or medication.
What safety measures are in place for the Paradise procedure?
The procedure has shown a favorable safety profile with no significant complications reported in clinical studies, ensuring patient wellbeing during treatment.
Is the Paradise uRDN system available for patient use?
Yes, the system is currently available in the United States following FDA approval and is recognized in various international markets.
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