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SentreHEART aMAZE Trial Receives FDA Approval for Stage II Expansion Based on 100 Subject Interim Safety and Performance Analysis

REDWOOD CITY, Calif. (BUSINESS WIRE) — SentreHEART, Inc., the manufacturer of the LARIAT® Suture Delivery Device (LARIAT) for percutaneous left atrial appendage (LAA) closure announces FDA approval to expand to Stage II of the aMAZE Trial. The approval comes as a result of prespecified analysis of adjudicated safety and performance results from initial 100 enrolled subjects by independent Data Monitoring Committee (DMC) and FDA.