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ReCor Medical and Otsuka Paradise uRDN System Meet its Primary Endpoint in the (RADIANCE II) US Trial for Hypertension

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ReCor Medical and Otsuka Paradise uRDN System Meet its Primary Endpoint in the (RADIANCE II) US Trial for Hypertension

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

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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