Recor Medical Advocates for Coverage of Renal Denervation Therapy
Recor Medical's Commitment to Hypertension Treatment
Recor Medical, Inc. is at the forefront of revolutionizing hypertension care. The company, along with Otsuka Medical Devices Co., Ltd., announced its enthusiastic support for the proposed National Coverage Determination (NCD) by the Centers for Medicare and Medicaid Services (CMS) regarding Renal Denervation (RDN). This innovative approach offers hope to patients struggling with uncontrolled hypertension, a condition that requires more than just lifestyle changes and medications.
Understanding the Proposed Changes
The recent proposal from CMS, which is currently open for public comment, recommends that ultrasound renal denervation (uRDN) and radiofrequency renal denervation (rfRDN) be covered for patients suffering from uncontrolled hypertension. Healthcare professionals and industry partners are invited to share their perspectives during a 30-day comment window. As CMS heads towards a final determination, which is expected soon, this development is highly anticipated by many in the medical community.
Impact on Patients with Uncontrolled Hypertension
CEO of Recor Medical, Lara Barghout, expressed optimism over CMS’s initiative, as it aligns with the company's mission to meet the needs of a population that currently faces significant challenges in managing their hypertension effectively. The preliminary determination is seen as a significant stride towards recognizing the clinical advantages of RDN, allowing better access to treatments that could greatly benefit patients.
The Paradise uRDN System: A Breakthrough Technology
For over a decade, Recor has dedicated its research and development efforts towards perfecting the Paradise uRDN system specifically for hypertension treatment. The comprehensive RADIANCE global program has validated this technology through three rigorous, randomized clinical trials involving more than 500 patients facing uncontrolled hypertension. The trials - RADIANCE II, RADIANCE-HTN SOLO, and RADIANCE-HTN TRIO - demonstrated that the Paradise system not only met its primary efficacy endpoints but also maintained a solid safety profile following the uRDN treatment.
Real-World Evidence Collection
In addition to prior trials, Recor has launched the US Global Paradise System (GPS) Post-Approval Study. This initiative aims to gather ongoing clinical data and provide long-term follow-up outcomes for 1,000 patients undergoing treatment for uncontrolled hypertension, further reinforcing the effectiveness of the Paradise technology.
Features of the Paradise uRDN System
This groundbreaking system gained FDA approval in late 2023, making it officially available for patients in the US. It serves as an adjunctive treatment option for those whose blood pressure remains unmanaged despite lifestyle modifications and antihypertensive medications. The technology functions by delivering targeted ultrasound energy to disrupt the overactive sympathetic nerves surrounding renal arteries, which is crucial in regulating blood pressure.
A Closer Look at the Technology
The operational mechanism of the Paradise uRDN system involves administering two to three doses of 360-degree ultrasound energy for seven seconds through the renal arteries. Importantly, the system includes a unique HydroCooling™ system, which circulates sterile water during the procedure to protect the renal artery wall, enhancing overall treatment safety.
About Recor Medical and Otsuka Medical Devices
Recor Medical, an entity headquartered in Palo Alto, California, operates as a subsidiary of Otsuka Medical Devices Co., Ltd. The company stands out for its commitment to innovating hypertension management through advanced technologies like the Paradise uRDN system. Not only is the Paradise system FDA approved in the US, but it also holds CE certification for markets that require it. With ongoing positive results from independent studies and additional registries launched in both the EU and the UK, Recor demonstrates a strong commitment to improving patient outcomes across various regions.
Frequently Asked Questions
What is the significance of the proposed NCD by CMS?
The proposed NCD supports Medicare coverage for uRDN procedures, expanding access for patients with uncontrolled hypertension who are in need of effective treatment options.
How does the Paradise uRDN system work?
The Paradise uRDN system uses ultrasound energy to denervate the sympathetic nerves around the renal arteries, which helps to lower blood pressure.
What are the expected outcomes of the ongoing studies?
The ongoing studies aim to gather long-term real-world data to validate the effectiveness and safety of the Paradise uRDN system in treating uncontrolled hypertension.
Why is the 30-day public comment period important?
This comment period allows healthcare professionals and stakeholders to provide insights that can shape the final determination by CMS, ensuring diverse perspectives are considered.
Where is Recor Medical headquartered?
Recor Medical is headquartered in Palo Alto, California, and operates under Otsuka Medical Devices Co., Ltd., focusing on hypertension management innovations.
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