Recor Medical has received regulatory approval for the manufacturing and marketing of its Paradise Ultrasound Renal Denervation (uRDN) system in Japan.
Paradise uRDN system targets sympathetic nerves surrounding the renal arteries to treat resistant hypertension.
The system employs ultrasound technology to deliver two to three doses of 360° ultrasound energy to each renal artery.
It aims to denervate the sympathetic nerves and reduce hypertension.
Paradise uRDN system features a HydroCooling system that circulates sterile water through the catheter to protect the renal arterial wall during the procedure.
Recor Medical said it is the first device approved in Japan, indicated for the treatment of resistant hypertension.
Recor Medical president and CEO Lara Barghout said: “We are pleased that the Paradise uRDN system is the first Renal Denervation device to be approved in Japan, making it the first treatment of its kind available to patients in the country.
“Hypertension knows no global boundaries. Expanding access to this innovative therapy is central to our mission, and we are passionate about providing transformative solutions that improve both the health and quality of life for patients around the world.”
The regulatory approval is based on positive results from the RADIANCE-HTN TRIO study, conducted in the US and Europe.
The clinical trial assessed the Paradise uRDN system in patients with resistant hypertension on triple antihypertensive therapy.
The study achieved its primary efficacy endpoint, showing a significant reduction in daytime ambulatory systolic blood pressure two months post-randomisation.
In addition to its recent approval in Japan, the Paradise uRDN system received the US Food and Drug Administration (FDA) approval in 2023 and holds a CE mark.
Recor Medical has launched the Global Paradise System post-market registry in the EU and UK and initiated a post-approval study in the US.
A post-marketing surveillance study is planned in Japan to gather long-term data.
