What's Happening?
Recor Medical has announced that its Paradise Ultrasound Renal Denervation (uRDN) system has received manufacturing and marketing approval in Japan for treating resistant hypertension. This marks the first approval of its kind in Japan, based on the successful RADIANCE-HTN TRIO study conducted in the U.S. and Europe. The system uses ultrasound technology to lower blood pressure by targeting sympathetic nerves around the renal arteries.
Why It's Important?
The approval of the Paradise uRDN system in Japan represents a significant advancement in the treatment of resistant hypertension, a condition that poses high risks and is difficult to manage with medication alone. This approval could expand treatment options for patients and potentially reduce the incidence of cardiovascular diseases, which are a leading cause of death in Japan. The system's success in clinical trials underscores its potential to improve patient outcomes and enhance the quality of life for those affected by hypertension.
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What's Next?
Following the approval, Recor Medical plans to conduct a post-marketing surveillance study in Japan to gather long-term data on the system's effectiveness and safety. The company is also focused on expanding access to the Paradise uRDN system globally, with ongoing studies in the EU, UK, and U.S. The successful implementation of this technology could pave the way for further innovations in hypertension management and strengthen Recor's position in the medical device market.
