Shockwave IVL System with the Shockwave C2+ Coronary IVL Catheter Adverse Events: FDA MAUDE Data
Shockwave Medical, Inc. · Intravascular Lithotripsy (Shockwave) · First cleared Feb 2021 · 8 device variants grouped
Total Reports
343
Reports (30d)
8
Active Signals
1
Open Recalls
0
Detection
Active safety signals
Evidence
Related research
Efficacy and safety of shockwave intravascular lithotripsy (S-IVL) in calcified unprotected left main percutaneous coronary intervention – short-term outcomes
Piotr Rola, et al. · Advances in Interventional Cardiology · 2021
Best Practice in Intravascular Lithotripsy
Benjamin Honton, et al. · Interventional Cardiology Reviews Research Resources · 2022
Treatment of severely calcified coronary artery disease by intravascular lithotripsy primary outcomes and 180-day follow-up from the Chinese SOLSTICE Trial
Feng Tian, et al. · 老年心脏病学杂志：英文版 · 2023
Efficacy and Safety of Intravascular Lithotripsy Versus Rotational Atherectomy in Balloon-Crossable Heavily Calcified Coronary Lesions
Mohamed A.A. Mousa, et al. · Cardiovascular revascularization medicine · 2022
Incidence of Periprocedural Myocardial Injury and Infarction After Intravascular Lithotripsy for Calcified Coronary Artery Stenosis
Gwaenaelle Aellen, et al. · Catheterization and Cardiovascular Interventions · 2026
Citations indexed from PubMed.
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