FDA approves CVRx's Barostim Neo, the first neuromodulation device for heart failure

CVRx/Barostim

The FDA approved Barostim Neo for heart failure with reduced ejection fraction in patients not indicated for cardiac resynchronisation therapy. In the BeAT-HF trial, patients given the device improved quality of life, walking distance and NYHA class compared with those on medication alone.

• 264 patients randomised: 130 Barostim, 134 guideline medical therapy
• Quality of life improved 14 points and 6-minute walk 60 m versus control
• NT-proBNP, a heart-strain marker, fell significantly
• CVRx was then privately held, founded 2001, based in Minneapolis