Recor Medical Achieves Landmark Coverage for Innovative Treatment
In a groundbreaking announcement, Recor Medical, Inc. has received significant news that will elevate the treatment options available for patients fighting uncontrolled hypertension. The Centers for Medicare and Medicaid Services (CMS) has officially issued a National Coverage Determination (NCD) for Renal Denervation (RDN), which encompasses Recor's innovative Paradise Ultrasound Renal Denervation (uRDN) system. This device offers a new avenue for individuals whose blood pressure remains high despite lifestyle adjustments and medication.
CEO Praises CMS for Paving the Way
Lara Barghout, the CEO of Recor Medical, expressed her appreciation for CMS's dedication in issuing this coverage determination. "This is a transformative milestone for patients across the U.S. who continue to battle uncontrolled hypertension,” she stated. The recognition from CMS underscores the clinical benefits of renal denervation and expands Medicare coverage, thereby enhancing access to this revolutionary treatment.
Hope for Patients Struggling with Hypertension
Barghout emphasized the importance of this decision, not only in confirming the safety and effectiveness of the Paradise uRDN system but also in bringing new hope to patients. It serves as a reminder of the impact that robust clinical research can have in improving cardiovascular health outcomes.
The Clinical Evidence Behind Paradise uRDN
Dr. Helen Reeve-Stoffer, Chief Clinical Officer, added to the conversation by highlighting the extensive clinical evidence supporting the efficacy of the Paradise uRDN system. Over the past several years, clinical trials have demonstrated significant reductions in blood pressure for patients suffering from uncontrolled hypertension, a persistent challenge within the cardiovascular sphere.
Years of Research and Trials
Recor's commitment to developing the Paradise uRDN system has been unwavering since 2009. The RADIANCE global program, which examined the uRDN system, included three randomized clinical trials that involved over 500 patients. These trials, known as RADIANCE II and RADIANCE-HTN SOLO, studied mild to moderate hypertension under controlled conditions, while RADIANCE-HTN TRIO focused on patients with resistant hypertension receiving triple antihypertensive therapy. All trials successfully met their primary efficacy endpoints and showcased a favorable safety profile post-treatment.
Current Availability of the Paradise uRDN System
The Paradise uRDN system, which has been commercially available for patients in the U.S. following its FDA approval, is indicated for use in cases where lifestyle changes and standard medications fail to adequately manage blood pressure. While the system has proven effective, potential side effects such as pain and vascular access complications may occur, and results can vary from patient to patient.
Innovative Technology Behind Paradise
What sets the Paradise uRDN system apart is its advanced technology. It employs ultrasound energy to denervate the sympathetic nerves around the renal arteries, tackling the overactivity linked to hypertension. Each treatment delivers two to three doses of 360-degree ultrasound energy for seven seconds via a specialized catheter featuring HydroCooling™ technology to safeguard renal artery integrity during the procedure.
About Recor Medical, Inc.
Recor Medical, Inc. is a subsidiary of Otsuka Medical Devices Co., Ltd., headquartered in Palo Alto. The company is focused on revolutionizing the management of treatment-resistant hypertension through the Paradise uRDN system, which has received FDA approval and is CE marked in various international markets, including Japan. Clinical studies have endorsed the effectiveness of the Paradise system across different patient populations, reinforcing Recor's commitment to delivering innovative healthcare solutions.
Continuing Advancements in Cardiovascular Treatment
As Recor advances its initiatives to gather real-world data through the Global Paradise System (GPS) Post-Market Registry, the organization remains dedicated to enhancing health outcomes for patients with challenging hypertension. Through ongoing clinical and post-marketing studies, Recor is poised to further its mission and improve the lives of countless individuals.
Frequently Asked Questions
What is the Paradise uRDN system?
The Paradise uRDN system is a medical technology designed to lower blood pressure for patients with uncontrolled hypertension, utilizing ultrasound energy to denervate renal nerves.
Why did CMS issue a National Coverage Determination?
CMS issued the NCD to formally recognize the clinical value of renal denervation treatments, expanding patient access to innovative therapies like the Paradise uRDN system.
What are the potential side effects of using Paradise uRDN?
Potential side effects include pain, complications at the vascular access site, and vasospasm, although results may vary by individual.
How long has Recor been developing the Paradise uRDN system?
Recor has been focused on developing the Paradise uRDN system since 2009, with rigorous clinical trials supporting its efficacy and safety.
Where can I find more information about Recor Medical?
More detailed information about Recor Medical and its products can be found on their official website.
