CVRx Gets FDA's Revised Instructions For Use Approval For Barostim
(RTTNews) - CVRx, Inc. (CVRX) Tuesday announced today that it has received the FDA approval for revised Instructions For Use or IFU for Barostim incorporating key long-term clinical data from the BeAT-HF randomized clinical trial.
The commercial-stage medical device company said IFU is a post-market phase validation.
Barostim delivers Baroreflex Activation Therapy to improve patients' heart failure functional status, six-minute hall walk, and quality of life.
In the Pre-Market Phase, all effectiveness endpoints were previously met, however, in the Post-Market Phase effectiveness, primary endpoint of CV death and HF hospitalization was not met.
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