The Paradise Ultrasound Renal Denervation (RDN) hypertension treatment system, made by Recor Medical and its parent company Otsuka Medical Devices, has been approved by the FDA. This is a big step toward changing the way hypertension is treated. Paradise is the first ultrasound-based RDN technique designed to deactivate renal artery sympathetic nerves, which effectively lowers blood pressure. This is a major step forward in medical technology.
Through each primary renal artery, the Paradise system sends two to three seven-second doses of 360° ultrasound energy to nerves nearby. This innovative approach represents a novel method for addressing hypertension, particularly when conventional methods such as lifestyle changes and pharmaceutical interventions prove ineffective.
A distinctive feature of the Paradise system is its patented hydrocooling mechanism embedded in the Paradise catheter. This mechanism circulates sterile water through the balloon catheter during surgery, acting as a safeguard to protect the renal artery wall. This additional layer of safety demonstrates the thoroughness and commitment to patient well-being in the development of this groundbreaking technology.
The FDA's approval of the Paradise Ultrasound RDN system follows a positive recommendation from the FDA Advisory Committee Panel in August 2023. This approval shows that the system works and is safe, proving that it can help with the important problem of uncontrolled high blood pressure when other treatments fail.
Recor Medical's President and CEO, Lara Barghout, expressed enthusiasm about the FDA approval, stating, "Recor is leading the way in bringing an innovative solution to clinicians and their patients struggling to control blood pressure. This FDA approval is the culmination of years of technical research and rigorous clinical studies."
The approval is based on the positive results of the randomized clinical study Radiance II. The Paradise Ultrasound RDN system met both the primary safety and effectiveness endpoints, and there were no reports of serious side effects. Ultrasonic RDN therapy was tested on over 500 people with uncontrolled high blood pressure as part of the RADIANCE worldwide program. The trials were sham-controlled, independently powered, and randomized. The results showed that the therapy works. Each trial not only met its primary effectiveness endpoint but also demonstrated a high level of safety.
This groundbreaking approval opens new horizons for patients facing challenges in managing blood pressure. With the Paradise Ultrasound RDN system now in the medical arsenal, clinicians have an innovative and effective tool to combat hypertension when conventional measures prove insufficient. Recor Medical's dedication to advancing medical solutions is evident, and the FDA's certification paves the way for a new era in hypertension management, offering hope to patients and healthcare providers alike.
