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CVRx’s Hypertension Implant Gains FDA Humanitarian Exemption

The humanitarian device exemption for the Barostim neo legacy implantable electronic stimulator for hypertension is CVRx’ first commercial approval in the U.S. The Minneapolis company is also developing the Barostim therapy for treatment of heart failure

FDA has granted a humanitarian device exemption for CVRx Inc.’sBarostim neo legacy implantable electronic stimulator for the treatment of drug-resistant hypertension, the first FDA approval of any kind for the private Minneapolis company.

The HDE, announced Dec. 16, is based on FDA’s determination that neo legacy is safe appropriate for patients previously defined as responders to CVRx’ earlier Rheos carotid sinus lead system,...

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