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AtriCure Gains Expanded Labeling for Atriclip, Braces LAA Arm

Zacks Equity Research

Shares of AtriCure, Inc. ATRC hopped 0.22% to close at $26.82 yesterday, subsequent to the company's receipt of the FDA’s 510(k) clearance for additional C claims of its well-acclaimed AtriClip left atrial appendage (LAA) management devices. This FDA approval validates the company's efforts in gaining ground in the field of coronary artery disease and other cardiovascular disorders.

The Labeling Claim and Prospects

The additional indication covers change from occlusion of the LAA to exclusion and also addition of electrical isolation as a labeling claim. Here, ‘exclusion’ shuts off and/or eliminates the appendage from the left atrium. Meanwhile, ‘occlusion’ plugs the opening to prevent flow into the LAA. Per AtriCure, the electrical isolation claim was granted after testing, which demonstrated that when the LAA is excluded using an AtriClip device, the appendage can no longer conduct electrical activity.

Given the fact that approximately 2.5 million adults in the United States suffer AF (with the market estimated to reach $14.68 billion by 2026 at a CAGR of 14.1% from 2018 onward, according to Reports and Data)and the number is only expected to shoot up further with the rise in aging population, we believe the aforementioned 510(k) clearance for additional labeling claims for the AtriClip device stands a good chance to enhance the company's profit margins, going ahead.

In this regard, the company noted that on a global scale, AtriClip devices are currently the most widely implanted left atrial appendage management devices and have been used in more than 190,000 procedures worldwide.

Over the last few years, the company has largely expanded its AtriClip devices’ labeling to reflect the growing clinical use of the equipment. With AtriCure’s plan to gain an additional labeling extension in the future, we presume its customer base to grow consistently.

Market Potential

Per Research and Markets, the global LAAC (LAA Closure) device market is projected to see a CAGR of 30.6% between 2018 and 2024. Further, the report states that increasing incidences of atrial fibrillation in aged population are likely to drive the global LAAC device market. 

Share Price Movement

Over the past year, shares of AtriCure have underperformed its industry. The stock has declined 23.9% against the industry's 1.2% growth.

Zacks Rank & Key Picks

Currently, AtriCure carries a Zacks Rank #3 (Hold). A few better-ranked stocks from the broader medical space are GW Pharmaceuticals PLC GWPH, EssilorLuxottica Societe anonyme ESLOY and Haemonetics Corporation HAE. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

GW Pharmaceuticals’ estimates third-quarter earnings growth rate is estimated at 72.77%. The stock sports a Zacks Rank #1,

Zacks #2 (Buy) Ranked EssilorLuxottica’s long-term earnings growth rate is predicted at 8.7%.

Haemonetics has a Zacks Rank #2 and a long-term earnings growth rate projection of 13.5%.

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