The U.S. Food and Drug Administration (FDA) has granted approval to Recor Medical’s innovative Paradise Ultrasound Renal Denervation (RDN) system for the treatment of uncontrolled hypertension. This approval marks the first time an RDN system designed specifically for hypertension has been authorized by the FDA.
Overview of the Paradise Ultrasound RDN System
The Paradise Ultrasound RDN system is intended for patients whose high blood pressure remains unmanageable with conventional medications. This advanced system utilizes ultrasound ablation to target and disrupt the nerves in the renal arteries. By interfering with these nerves, the system prevents the constriction of the arteries.
The treatment process involves:
- Ultrasound Energy: The system delivers two to three brief doses of ultrasound energy, each lasting seven seconds.
- Sterile Water Circulation: A balloon catheter filled with sterile water is used to support the renal artery walls and facilitate the transmission of ultrasound waves during the procedure.
This approach helps to keep the renal arteries open, thereby enhancing blood flow to the kidneys and aiding in the removal of excess water from the body, which can help reduce hypertension.
Statements from Key Figures
Laura Barghout, President and CEO of Recor Medical, expressed enthusiasm about the FDA’s approval: “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. We are grateful to the patients who participated in the studies and to the clinical trial investigator teams whose diligence and dedication made FDA approval possible. We look forward to making this technology available to physicians and their patients nationwide.”
Noriko Tojo, President of Otsuka Medical Devices, Recor Medical’s parent company, highlighted the importance of the approval: “Approval of the Paradise Ultrasound RDN system marks an important milestone for the company and provides a new adjunctive treatment option for hypertension, which remains inadequately controlled despite conventional therapies.”
Implications for Patients
For individuals experiencing hypertension that does not respond to traditional treatments, the Paradise Ultrasound RDN system represents a promising new option. As this technology becomes more widely available, it has the potential to offer significant benefits to patients struggling to manage high blood pressure effectively.
