SentreHEART Announces 400th Patient Enrollment in the Landmark aMAZE Trial
Redwood City, CA- September 5, 2018 (BUSINESS WIRE) SentreHEART, Inc., manufacturer of the LARIAT® Suture Delivery Device (LARIAT) for percutaneous left atrial appendage (LAA) closure announces enrollment of the 400th patient in the prospective, multi-center, randomized controlled Trial known as the aMAZE Trial. The Trial is a superiority design and intends to demonstrate the LARIAT procedure for LAA closure, when used in adjunct with subsequent Pulmonary Vein Isolation (PVI) catheter ablation, will lead to a reduced incidence of recurrent atrial fibrillation (AFib) compared to PVI alone in those patients that suffer from drug-refractory, persistent and longstanding persistent AFib.
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.