Key result
FDA MAUDE database search details adverse events and catheter failures linked to IVL.
Why the study?
Real-world safety and adverse event data for intravascular lithotripsy in treating de novo calcified coronary lesions are limited.
Observational
Analysis of the FDA MAUDE database provides real-world safety and adverse event profiles for coronary intravascular lithotripsy.
Answers are grounded in this paper and cite their sources.
MAUDE search for intravascular lithotripsy events yields no quantitative data; leaves open real-world safety assessment.
Percutaneous coronary intervention (PCI) on heavily calcified lesions has been associated with more complications.1 Intravascular lithotripsy (IVL) was recently approved for treating de novo calcified coronary lesions based on excellent safety and efficacy on several studies, but there are limited "real world" outcomes. We conducted a comprehensive search of the MAUDE database between February 12, 2021, and February 28, 2023 using the manufacturer and brand name tabs with the keywords "Shockwave Medical" and "Shockwave," respectively. Given that a single IVL catheter can fail or cause multiple adverse events through different mechanisms, we considered all possible outcomes. The MAUDE database is freely accessible and de-identified, obviating the need for institutional review board approval.
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Rempakos et al. (2023) conducted an observational in heavily calcified coronary lesions. Intravascular lithotripsy (IVL) was evaluated on Adverse events and catheter failures. A search of the FDA MAUDE database for adverse events associated with intravascular lithotripsy was conducted, but the abstract reports no quantitative results.
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