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EUROPE: The CVRx BAROSTIM NEO System is CE Marked and approved for sale for hypertension patients in Europe. It is also CE Marked and approved for sale for heart failure patients in Europe.
UNITED STATES: CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.
CAUTION: Federal law restricts this device to sale by or on the order of a physician. Humanitarian Device. Authorized by Federal law for use in the treatment of resistant hypertensive patients implanted with the Rheos CSL leads. The effectiveness of this device has not been demonstrated.
CANADA: Caution: Exclusively for Clinical Investigations
For a list of all potential benefits and risks go to www.cvrx.com/benefit-risk-analysis/