REDWOOD CITY, Calif.--(BUSINESS WIRE)--SentreHEART, Inc., the manufacturer of the LARIAT® Suture Delivery Device (LARIAT) will be participating in the American Heart Association (AHA) Scientific Sessions 2017 in Anaheim, California November 11-15, 2017. AHA’s Scientific Sessions attracts nearly 18,000 attendees, with a global presence from more than 100 countries.
With a commitment to clinical evidence development, SentreHEART is presently sponsoring the FDA-approved, 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 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. Attendees of the AHA Scientific Sessions who are interested in learning more about the aMAZE Trial may visit SentreHEART’s Booth #2243 in the Exhibit Hall during the sessions or visit www.amazetrial.com.
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.
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.
SentreHEART is a privately owned medical device company based in Redwood City, CA. 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