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SentreHEART Announces Participation at CSI LAA 2017 Frankfurt ConferenceSentreHEART, Inc., the manufacturer of the LARIAT® Suture Delivery Device (LARIAT) will be participating in the CSI (News - Alert) LAA 2017 Scientific Program being held in Frankfurt, Germany November 17-18, 2017. This 2-day course will provide an overview of all aspects of Left Atrial Appendage closure as a treatment modality for patients diagnosed with Atrial Fibrillation (AFib). Featured presentations in the scientific program include:
With a commitment to clinical evidence development, SentreHEART is presently sponsoring the FDA-approved, rospective, multi-center, randomized controlled Trial known as the aMAZE Trial. The Trial is a superiority design and intends to demonstrate the LARIAT procedure for Left Atrial Appendage (LAA) closure, plus a subsequent PVI ablation will lead to a reduced incidence of recurrent Atrial Fibrillation (AFib) compared to Pulmonary Vein Isolation (PVI) alone; with a high safety profile. In May 2017, SentreHEART received FDA approval to expand to Stage II of the Trial based on the pre-specified analysis of adjudicated safety and performance results of the initial 100 enrolled subjects by independent Data Monitoring Committee (DMC) and FDA. Having a non-implant option that may both electrically and mechanically isolate the LAA is a potentially important addition to the treatment armamentarium for clinicians treating patients with persistent or longstanding persistent AFib. The LARIAT has the potential to eliminate the LAA as a source of AFib and nidus for thrombus. Attendees of the CSI LAA 2017 Conference interested in learning more about the LARIAT are encouraged to visit SentreHEART's Booth and participate in a hands-on training session with a clinical specialist. ABOUT THE LARIAT SUTURE DELIVERY DEVICE The LARIAT Suture Delivery Device is indicated for suture placement and knot tying in surgical procedures where soft tissues are being approximated and/or ligated with a pre-tied polyester suture. SentreHEART received FDA 510(k) clearances for the LARIAT in 2006, 2009, 2014, and 2016. The LARIAT device is also CE Marked in Europe. ABOUT SENTREHEART SentreHEART is a privately owned medical device company based in Redwood City, CA (News - Alert). Founded in 2005, SentreHEART has developed technology for remote delivery of suture for closure of anatomic structures. aMAZE is an FDA-approved Trial - U.S. FDA IDE# G150107 Clinicaltrials.gov Identifier: NCT02513797
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