Recor Medical and its parent company, Otsuka Medical Devices, have introduced the Paradise Ultrasound Renal Denervation (uRDN) system in the US, following its approval by the US Food and Drug Administration (FDA).
The first commercial application of the system was carried out by Doctors Ajay J Kirtane and Sahil A Parikh at NewYork-Presbyterian/Columbia University Irving Medical Center.
Doctors Suhail Dohad and Raj Makkar have also utilised the system at the Smidt Heart Institute at Cedars-Sinai in Los Angeles, Dr Aravinda Nanjundappa, an interventional cardiologist at Cleveland Clinic and Dr Vijay Iyer at Gates Vascular Institute in Buffalo, New York.
The system denervates overactive sympathetic nerves surrounding the renal arteries to reduce blood pressure.
It administers two to three doses of 360°ultrasound energy, each lasting seven seconds, targeting the surrounding nerves through the main renal arteries.
The Paradise catheter comes with the exclusive HydroCooling system that circulates sterile water through the balloon during the procedure to cool and protect the renal artery’s inner layers.
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Meanwhile, the Paradise uRDN system was evaluated through the company’s RADIANCE Global Programme, which consists of three prospectively powered and sham-controlled randomised controlled clinical studies.
The trials include RADIANCE-HTN TRIO, which assessed patients with resistant hypertension, the RADIANCE-HTN SOLO and the RADIANCE II studies, which evaluated patients with mild-to-moderate hypertension.
Each study achieved its prespecified primary efficacy endpoint, demonstrating statistically significant and clinically meaningful blood pressure reductions against a sham arm and favourable safety profiles.
Nanjundappa said: “This new renal denervation technology for a high-risk patient population, individuals with difficult-to-control hypertension, has been long awaited. We look forward to offering this procedure now to those that will likely derive benefit.”