Possis' AngioJet Thrombectomy System Approved For Coronary Indications
This article was originally published in The Gray Sheet
Executive SummaryUse of Possis Medical's AngioJet Thrombectomy System in the heart requires placement of a "temporary pacing catheter to support the patient through hemodynamically significant arrhythmias which may occur," according to a bolded statement appearing in the "Warnings and Precautions" section of FDA-approved labeling for the new indication.
You may also be interested in...
Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.
Keeping Track: Approvals For Tazverik And Tepezza, Priority Reviews For Belantamab Mafodotin And Lynparza
The latest drug development news and highlights from our US FDA Performance Tracker.
Accelerated approval in epithelial sarcoma may de-risk the firm’s goals for approval of Tazverik in follicular lymphoma and other larger indications.