Shots:
The (RADIANCE II) US IDE trial evaluating Paradise ultrasound renal denervation (uRDN) system in 224 patients with uncontrolled hypertension prior treated with ~2 medications at 60+ study centers in 8 countries
The trial met its primary efficacy EPs & demonstrated a significant reduction in daytime ambulatory systolic blood pressure b/w uRDN system & a sham procedure @2mos.
The Paradise system received the CE mark in the EU & become an important treatment option to control blood pressure. ReCor intends to submit the results of its RADIANCE global program as part of a PMA to the US FDA for market approval & has initiated a GPS registry in the EU with an expected plan to expand it globally
Ref: Bussinesswire | Image: ReCor Medical
