Edwards Lifesciences LLC · Replacement Heart Valve (Surgical/Transcatheter) · First cleared Sep 1991
Total Reports
483
Reports (30d)
2
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Template Summary: Implant Patient Registry Overview
patient registry, registry, data, registry ipr, ipr registry
1
reports
Transcatheter Valve-In-Valve Procedure After 17 Years
procedure implant, transcatheter valve, valve procedure, underwent valve, transcatheter
1
reports
Valve Explant Due to Calcification and Stenosis
replaced, explanted implant, implant duration, valve explanted, explanted
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Propensity-adjusted 8-year outcomes following bioprosthetic aortic valve replacement: The influence of novel anticalcification technology
Tsuyoshi Kaneko, et al. · JTCVS Open · 2025
Exploratory Cost-Effectiveness of a Novel Bioprosthetic Valve for Surgical Aortic Valve Replacement in Spain
María Ascaso, et al. · PharmacoEconomics - Open · 2025
Citations indexed from PubMed.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.
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