California Compliance Statement
California Proposition 65
Code of Business Ethics
Otsuka Holdings Co., Ltd.
The PARADISE™ system is FDA approved for sale in the United States and is CE marked and approved for sale in markets where the CE mark is accepted.
© 2025 Recor Medical, Inc. All rights reserved. The PARADISE™ system is FDA approved for sale in the United States and is CE marked and approved for sale in markets where the CE mark is accepted, per approved indications for use. For investigational use only in Japan. RECOR MEDICAL, PARADISE, HYDROCOOLING, SONOWAVE 360, RADIANCE, the GPS logo, and the Swirl logo are registered trademarks in the EU and the other countries, RECOR and the RADIANCE logo are also trademarks of Recor Medical, Inc. EMEA 03/2025
Important Safety Information
Prescription Only. Brief Summary – Prior to use, please reference the Instructions for Use
Indications for Use
The Paradise™ Ultrasound Renal Denervation System (Paradise™ System) is indicated to reduce blood pressure as an adjunctive treatment in hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure.
Results may vary. The most common risks include pain, vascular site injury and vasospasm. See full important safety information: https://www.recormedical.eu/paradise-ultrasound-rdn-system/#safety
Recor Medical, headquartered in Palo Alto, California, USA, a wholly owned subsidiary of Otsuka Medical Devices Co., Ltd. recormedical.eu is Recor Medical, Otsuka Medical Devices Europe GmbH website (the Site). We control and operate this Site from Europe. This Site is intended for use by European residents only and contains information regarding the Paradise™ System, which is approved for sale in the EU and bears a CE mark.
Recor Medical Europe GmbH
Europa-Allee 52 · 60327 Frankfurt · Germany
Amtsgericht Frankfurt am Main: HRB 123214
Chief Executive Officers: Lara Barghout, Michael Jones, Ronan O`Connor
