News | Left Atrial Appendage (LAA) Occluders | August 28, 2019

AtriCure Receives Clearance for Expanded Labeling Claims for AtriClip Devices

Clinical evidence demonstrates that AtriClip devices exclude and electrically isolate the left atrial appendage

AtriCure Receives Clearance for Expanded Labeling Claims for AtriClip Devices

August 28, 2019 — AtriCure Inc. announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance of additional labeling claims for AtriClip left atrial appendage (LAA) management devices. These include changing the indication from occlusion of the LAA to exclusion, and also adding electrical isolation as a labeling claim.

Exclusion shuts off and/or eliminates the appendage from the left atrium, whereas occlusion plugs the opening to prevent flow into the LAA. The electrical isolation claim was granted after testing demonstrated that when excluding the LAA using an AtriClip device, the appendage can no longer conduct electrical activity.

AtriClip devices have been used in more than 190,000 procedures worldwide, according to the company. Over the past several years, new iterations of the AtriClip device have been developed and brought to market. These include enhancements to make the devices less invasive, amenable to a wider range of patient anatomies, and adaptable to varying operator preferences and techniques. These new labeling claims reflect that AtriClip devices exclude the appendage, resulting in eliminating it as a source of electrical activity through the process of ischemic necrosis. The safety and effectiveness of AtriClip devices in rhythm control management of an atrial arrhythmia, either alone or in combination with ablative treatment, has not been established.

“Historically, the surgical amputation of the left atrial appendage in a cut-and-sew fashion was considered to be the gold standard for LAA management," said S. Patrick Whalen, M.D., from Wake Forest Baptist Health. "The AtriClip device mimics the gold standard by eliminating the LAA by epicardial, mechanical closure. The subsequent ischemic necrosis process ceases all electrical activity in the LAA perioperatively and the appendage is ultimately resorbed.”

"Our research has defined a clear benefit of the electrical isolation of the LAA," said Dhanunjaya Lakkireddy, M.D., from Kansas City Heart Rhythm Institute (KCHRI). "The AtriClip device excludes the left atrial appendage in a manner that could result in its electrical isolation.”

For more information:

Related Content

AtriCure Receives FDA Clearance for New AtriClip Device

AtriCure Launches AtriClip FLEX•V Device in the United States

Related Content

Complete Revascularization Superior to Culprit Lesion-only Intervention
News | Cath Lab | September 10, 2019
An international randomized trial has shown that complete revascularization reduces major cardiovascular events...
The cath lab staff UH Portage Medical Center.

The cath lab staff UH Portage Medical Center.

Feature | Cath Lab | September 09, 2019 | Anjan Gupta, M.D., FACC, FSCAI
Primary percutaneous coronary intervention (PCI) is the preferred treatment for acute...
FDA Grants Shockwave Medical Breakthrough Status for Coronary Intravascular Lithotripsy
News | Cath Lab | September 03, 2019
Shockwave Medical Inc. has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA)...
Compound Could Help Improve Heart Attack Recovery
News | Cath Lab | August 27, 2019
Imagine there were a drug that you could take soon after a heart attack that could reduce damage by protecting healthy...
New Alliance Announced Between Transcatheter Cardiovascular Therapeutics and VEITHsymposium
News | Cath Lab | June 20, 2019
VEITHsymposium and the Cardiovascular Research Foundation (CRF) announced an alliance between Transcatheter...
Novel Index Accurately Predicts PCI Success Post-Procedure Compared to Established Measurement Metrics
News | Cath Lab | June 19, 2019
Results from a comprehensive analysis demonstrate the effectiveness of measuring a non-hyperemic pressure ratio (NHPR...
Philips Healthcare, Volcano IVUS showing an implanted stent. IVUS might offer an alternative to contrast angiography in patients with acute kidney disease (AKD).
News | Cath Lab | June 14, 2019
June 14, 2019 – A late-breaking study examined the effects of intravascular ultrasound (IVUS) guided drug-eluting ste
Videos | Cath Lab | May 20, 2019
This is a walk through of the primary structural heart hybrid cath lab at...
Overlay Init