SentreHEART Announces Initial Clinical Use of the LARIAT® with EpiRAILÔ Procedure for Left Atrial Appendage Exclusion
REDWOOD CITY, CA- SentreHEART, Inc., announced it has successfully completed nine First-In-Human procedures utilizing the LARIAT® with EpiRAILÔ at John Paul II hospital in Krakow, Poland. The LARIAT with EpiRAIL is an epicardial-only, percutaneous approach to complete and permanent closure of the left atrial appendage (LAA) in patients with atrial fibrillation and increased risk of stroke. All cases were performed by Dr. Krzyzstof Bartus of John Paul II Hospital and Dr. Randy Lee of UCSF. The EpiRAIL received CE mark clearance and will undergo continued evaluation at European centers.
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.