FDA has expanded the label for AtriCure’s left atrial appendage management devices, clearing the company to market the products in new ways.
The revised FDA label, which AtriCure disclosed Tuesday, indicates the devices for use in the exclusion of the LAA and features a new claim of electrical isolation.
AtriCure secured the expanded label shortly after posting another quarter of growth for its LAA franchise.
Interest in cutting the LAA off from the rest of the cardiovascular system stems from evidence the appendage is the source of most of the blood clots that put atrial fibrillation patients at increased risk of stroke. Boston Scientific responded to that evidence by introducing Watchman, a permanent heart implant that closes off the LAA. Other companies, including the SentreHeart business AtriCure bought for $40 million upfront this month, designed devices to close the LAA using sutures.
AtriCure has carved out a piece of the market with devices that clip off the LAA. Originally, the FDA label classed these devices as occluding the LAA, meaning they blocked the opening to stop the flow of blood through the appendage.
The new label changes the indication from occlusion to exclusion, which AtriCure said demonstrates that the device “shuts off and/or eliminates the appendage from the left atrium,” rather than simply blocking an opening.
That change contributed to AtriCure being able to get a claim of electrical isolation added to the FDA label. Testing showed the excluded LAA is unable to conduct electrical activity, leading to the new label claim.
The clearance is the latest in a series of label expansions for the AtriClip FLEX.V device and other products in the LAA range. Those expansions have contributed to the devices being a source of growth for AtriClip.
"We again realized very strong growth from the AtriClip FLEX.V device along with volume increases in minimally invasive LAA exclusion system devices. We remain confident in sustaining growth rates for our appendage management products," AtriCure CFO Andy Wade said on a second quarter results conference call with investors late last month.
AtriCure expects to seek further changes to the labels of its LAA devices in the future.