FDA Approves CVRx’s Advanced Heart Failure Treatment

The FDA granted CVRx approval for its Barostim Neo system, a technology designed to improve symptoms in patients with advanced heart failure who can’t be treated with other heart failure devices.

Advanced heart failure can cause fatigue, palpitation and shortness of breath, leading patients with the condition to receive no benefit from standard treatments.

The Barostim Neo was one of the first therapies to receive the FDA's Breakthrough Device designation, which led to prioritized review of a phase 3 trial in 264 patients, which showed  positive safety and effectiveness results.