Dive Brief:

• Abbott Laboratories received FDA approval for its Amplatzer Amulet left atrial appendage occluder device used to treat patients with atrial fibrillation who have a risk of stroke.
• The approval sets the stage for a fight over U.S. market share with Boston Scientific's Watchman device. The U.S. left atrial appendage market is currently valued at $500 million, according to an emailed statement from PR firm working for Abbott. FDA approval was supported by trial results from a head-to-head study with Watchman, which the company plans to release Aug. 30 during the European Society of Cardiology 2021 Congress, Abbott said. 
• CEO Robert Ford said during a July 22 earnings call that the device, which received a CE mark in 2013, makes up about 50% of the market in Europe, giving Abbott confidence it can successfully compete in the U.S. market.

Dive Insight:

Irregular heartbeats from atrial fibrillation can cause blood to build up in a small pouch, or appendage, located in the left atrium of the heart, where the blood can then clot and cause a stroke if those clots are pumped through the body and reach the brain.

Devices like Boston Scientific's Watchman and Abbott's Amulet close up the left atrial appendage for patients that cannot take blood thinners, preventing blood from pooling and clotting in the appendage.

Watchman has been a successful product for Boston Scientific; however, Amulet could chip away at the product's U.S. dominance now that it will enter the market.

During the July investor call, Abbott's Ford would not project any specific revenue or sales figures from Amulet in 2021. However, the CEO said the device would be a boost for the company if the approval did not come too late in the year.

In a June survey from SVB Leerink, 64 interventional cardiologists in the U.S. projected that Amulet would be used in nearly a quarter of their procedures after just approximately two years on the market.

Assuming a 2021 approval, respondents projected Amulet would be used in 10% of their procedures by the end of the year. The devices would then grow to about 19% of procedures by the end of 2022 and 24% by the end of 2023.

"This meaningful share shift to us suggests that physicians have high expectations for Amulet and expect it to play a meaningful role in their [left atrial appendage closure] practice," the analysts wrote. "Notably, no physicians surveyed expect Amulet to gain 100% share at their centers, with only nine of 64 physicians surveyed projecting [Abbott] to gain 50%+ share by 2023."

The analysts said the data was surprising but cautioned that the survey took place before Abbott's head-to-head study with Watchman has been released.

While the trial should be successful enough to gain FDA approval through non-superiority on several metrics, the analysts wrote, they "don’t expect the data to compare favorably against WATCHMAN from a superiority perspective."