SentreHEART Receives CE Mark for LARIAT-RS™ 50mm and Expanded Indication for Left Atrial Appendage Exclusion
REDWOOD CITY, Calif.--(BUSINESS WIRE)-- SentreHEART, Inc., announced it has received CE Mark for the LARIAT-RS™ 50mm as well as expanded labeling for the LARIAT-RS for left atrial appendage (LAA) exclusion. The new 50mm device along with the 45mm LARIAT-RS is now available for sale in Europe.
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LARIAT LAA Closure (Graphic: Business Wire)
The LARIAT-RS (LARIAT) device is differentiated from all other percutaneous LAA closure devices in Europe being the only non-implant solution for complete and permanent exclusion of the LAA. Using fluoroscopic and echocardiographic imaging guidance, the LARIAT enables clinicians to precisely deliver a pre-tied suture loop to the base of the LAA from the outside that leaves no metal or foreign material inside of the heart. Over time, the LAA will disappear and no longer be a source for blood clots in patients with atrial fibrillation.
Patients with atrial fibrillation (AFib) are five times more likely to suffer a stroke than those with normal sinus rhythm1. The LAA is recognized as the primary source of stroke-causing blood clots originating from the heart in patients with non-valvular atrial fibrillation2. By closing the LAA, it is believed the incidence of stroke may be reduced thus eliminating the requirement for life-long anticoagulation.
SentreHEART, the manufacturer of the LARIAT® Suture Delivery Device, is presently conducting the prospective, multi-center, randomized controlled Trial known as the aMAZE Trial (https://amazetrial.com) in up to 65 centers within the United States. 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 AFib compared to PVI alone in those patients that suffer from drug-refractory, persistent and long-standing persistent AFib.
Unlike LAA implant solutions for AFib, the aMAZE Trial seeks to potentially treat an underlying disorder of AFib by mechanically and electrically isolating the base of the LAA in a single step using the percutaneous, non-implant LARIAT suture delivery device.
Studies have demonstrated the LARIAT not only closes the LAA mechanically3 but may also isolate electrical activity4 within the LAA. 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.
Clinicaltrials.gov Identifier: NCT02513797
U.S. FDA IDE #G150107
About SentreHEART, Inc.
SentreHEART is a privately owned medical device company based in Redwood City, CA. Founded in 2005, SentreHEART has developed innovative technology for remote delivery of suture for closure of anatomic structures including the left atrial appendage.
- "Atrial Fibrillation Fact Sheet." Centers for Disease Control and Prevention. http://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_atrial_fibrillation.htm.
- Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg. 1996;61:755-759.
- 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
- Han F, et al. The Effects of LAA Ligation on Electrical Activity. Heart Rhythm. 2014 May; 11(5):864-70
Source: SentreHEART, Inc.
Senior Director of Marketing
Source: SentreHEART, Inc.