SentreHEART Announces Participation at The American College of Cardiology’s 67th Annual Scientific Session & Expo
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The meeting’s agenda includes several sessions dedicated to exploring device-based options for Left Atrial Appendage (LAA) closure in patients diagnosed with atrial fibrillation (AFib). Physician thought leaders in this field will be relating their experience and presenting data, which will include transpericardial LAA closure with the LARIAT in multiple AFib patient populations.
Studies have demonstrated the LARIAT not only closes the LAA mechanically1 but may also isolate electrical activity within the LAA2. 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, in its unique superiority design, targets the most challenging AFib population of persistent and long-persistent AFib patients, is intended to demonstrate a LARIAT procedure for LAA closure, plus a subsequent PVI ablation will lead to a reduced incidence of recurrent AFib compared to PVI alone; with a high safety profile.
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 ACC.18 who are interested in learning more about the aMAZE Trial and LARIAT procedure may visit the SentreHEART Booth #2757 in the Exhibit Hall during the meeting.
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 and 2014. 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
For more information, please visit www.amazetrial.com and follow us on Twitter @amazetrial.
1 Bartus K, et al. Percutaneous Left Atrial Appendage Suture Ligation Using the LARIAT Device in Patients with Atrial Fibrillation. J Am Coll Cardiol 2013 Jul 9;62(2):108-18
2 Han FT, et al. The Effects of LAA Ligation on Electrical Activity. Heart Rhythm. 2014 May; 11(5):864-70
Leslie J. Hines
Source: SentreHEART, Inc.