REDWOOD CITY, Calif.–(BUSINESS WIRE)–SentreHEART, Inc., the manufacturer of the LARIAT® Suture Delivery Device (LARIAT) will be participating in the Transcatheter Cardiovasular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, in Denver, CO October 29 – November 2, 2017. The symposium’s agenda will include 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.
AFib is an irregular, rapid heartbeat or quivering of the upper chambers of the heart called the atria due to a malfunction in the heart’s electrical system. It is the most common sustained arrhythmia and a major global public health problem due to its associated morbidity, including stroke and heart failure, diminished quality of life, and increased mortality. Current estimates indicate that approximately 33.5 million individuals have AFib worldwide, with close to 5 million new cases occurring each year.1
PVI Catheter ablation is the standard of care in the management of drug-refractory symptomatic AFib. However, the success rates of PVI ablation are less than ideal, especially in patients with persistent AFib.2 Current data suggests that a single ablation procedure of the pulmonary veins (PV) for treating AFib results in long-term success rates of only 20%-40%.
The LAA has been shown to play a role in the initiation and maintenance of atrial arrhythmias and is the source of most stroke-causing blood clots (thrombus) in AFib patients.3 Studies have demonstrated the LARIAT not only closes the LAA mechanically4 but may also isolate electrical activity within the LAA5.
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 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. 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 2017 TCT who are interested in learning more about the aMAZE Trial may visit SentreHEART’s Booth #4004 in the Exhibit Hall during the symposium 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.
ABOUT SENTREHEART
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
1 Afzal M, etal. Impact of Left Atrial Appendage Exclusion Using an Epicardial Ligation System (LARIAT) on Atrial Fibrillation Burden in Patients with Cardiac Implantable Electronic Devices, Heart Rhythm
2 Lakkireddy D, et al. Left Atrial Appendage Ligation and Ablation for Persistent Atrial Fibrillation, JACC: Clinical Electrophysiology 2015; VOL. 1, NO. 3
3 Manning WJ. Atrial fibrillation, transesophageal echo, electrical cardioversion, and anticoagulation. Clin Cardiol. 1995; 18: 58,114.
4 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
5 Han FT, et al. The Effects of LAA Ligation on Electrical Activity. Heart Rhythm. 2014 May; 11(5):864-70
Contacts
SentreHEART, Inc.
Leslie J. Hines
LHines@sentreheart.com
