PR Newswire Clinical TrialsOriginal article
FastWave Medical Gains FDA IDE Approval to Begin Pivotal Trial of Artero™ Peripheral IVL System
RegulatoryapprovedArtero™ Peripheral IVL SystemPositive
AI Analysis
Summary
FastWave Medical has received FDA IDE approval to initiate a pivotal U.S. trial evaluating its Artero™ Peripheral IVL System, an electric intravascular lithotripsy device designed to treat patients with peripheral artery disease.
Clinical Trial Data
Phase
pivotal
Outcome Details
FDA approval of IDE (Investigational Device Exemption) to begin pivotal trial
Importance:7/10
Sentiment:
0.80
FDA approvalIDE approvalintravascular lithotripsyperipheral artery diseasemedical devicepivotal trial
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Published by PR Newswire Clinical Trials on August 11, 2026 12:39 PM