CVRx Receives the US FDA’s Approval on the Label Expansion of Barostim
Shots:
- The revised IFU was approved for Barostim based on the long-term results from the post-market phase of the clinical trial (BeAT-HF)
- The updated IFU states that Barostim is indicated to treat patients with NYHA Class III or Class II, who have a left ventricular ejection fraction of ≤35% & NT-proBNP <1600 pg/ml
- A symptomatic improvement for patients with heart failure was seen in the 1EP results from 6/12/24mos. data, included in the revised clinical summary section of the IFU. While all efficacy EPs were previously met in the pre-market phase with improvements in 6MHW, QoL, NYHA Class & NT-proBNP, the 1EP of CV death & HF hospitalization was not met in the post-marketing phase, but showed a positive effect of Barostim
Ref: Globenewswire | Image: CVRx
Related News:- CVRx's Barostim Neo Device Receives the US FDA's Approval as World's First Heart Failure Neuromodulation Device
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
