AtriCure Announces that the First Patient has been Treated with the Revolutionary AtriClip® FLEX-Mini™ Device

Rhea-AI Summary

AtriCure, Inc. (Nasdaq: ATRC) has announced the successful treatment of the first patient with its newly 510(k) cleared AtriClip® FLEX-Mini™ device. This innovative product is now the smallest profile surgical LAA device available in the market, building upon AtriCure's proven AtriClip platform. The FLEX-Mini offers enhanced access and increased visibility for physicians, featuring a fully enclosed design with parallel beams for continuous closing force.

Key features of the AtriClip FLEX-Mini include:

• Low-profile design for improved visibility
• Ergonomic handle for single-handed placement
• Optimal pressure on atrial tissue

With nearly 600,000 AtriClip devices sold globally, AtriCure continues to lead the market in surgical LAA management, addressing atrial fibrillation and post-operative pain management.

Positive

• First patient successfully treated with the new AtriClip® FLEX-Mini™ device
• 510(k) clearance received for the AtriClip FLEX-Mini
• Smallest profile surgical LAA device on the market
• Enhanced access and increased visibility for physicians
• Nearly 600,000 AtriClip devices sold globally

Negative

• None.

Medical Device Expert

The launch of AtriCure's AtriClip® FLEX-Mini™ device marks a significant advancement in left atrial appendage (LAA) management. As the smallest profile surgical LAA device available, it addresses a critical need in cardiac surgery. The device's fully enclosed design and parallel beams for continuous closing force are key features that ensure optimal pressure on atrial tissue, potentially improving patient outcomes.

The ergonomic handle enabling single-handed placement is a notable improvement, potentially reducing procedural complexity and time. This innovation could lead to increased adoption among surgeons, especially in minimally invasive procedures where space and visibility are However, long-term clinical data will be important to fully assess its efficacy and safety compared to existing options.

Cardiology Specialist

The introduction of the AtriClip FLEX-Mini is a promising development in stroke prevention for atrial fibrillation patients. With nearly 600,000 AtriClip devices sold globally, the platform has demonstrated significant clinical impact. The device's smaller profile could potentially expand its use to a broader patient population, including those with challenging anatomies.

The highest-level recommendation for mechanical appendage closure from multiple physician societies underscores the importance of LAA management in reducing stroke risk. This new device may further solidify AtriCure's market leadership position. However, it's important to monitor real-world performance and compare outcomes with pharmacological approaches like anticoagulation therapy to fully understand its place in comprehensive Afib management.

Financial Analyst

AtriCure's launch of the AtriClip FLEX-Mini strengthens its position in the growing LAA management market. As the market leader with nearly 600,000 devices sold, this innovation could drive further revenue growth and market share expansion. The device's unique features may lead to increased adoption rates among surgeons, potentially boosting sales volumes.

Investors should note that while this product launch is positive, its financial impact may take time to materialize. Key factors to watch include adoption rates, pricing strategy and reimbursement policies. The 510(k) clearance is a regulatory win, but ongoing clinical studies and real-world evidence will be important for long-term success. AtriCure's focus on innovation in this high-growth segment aligns well with market trends, potentially supporting sustained revenue growth.

MASON, Ohio--(BUSINESS WIRE)-- AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatments and therapies for atrial fibrillation (Afib), left atrial appendage (LAA) management, and post-operative pain management, today announced that the first patient was treated with the AtriClip^® FLEX-Mini™ device, which recently received 510(k) clearance. The AtriClip FLEX-Mini sets a new standard as the smallest profile surgical LAA device on the market and builds upon the proven technology of AtriCure’s AtriClip platform, with ease of use and design simplicity that offers enhanced access and increased visibility for physicians.

“The AtriClip FLEX-Mini is an unparalleled product that reinforces our position as the market leader in surgical LAA management,” said Michael Carrel, President and Chief Executive Officer at AtriCure. “With nearly 600,000 AtriClip devices sold globally, we are having a significant impact on patients’ lives. Continuing to innovate and enhance the unique features of our AtriClip platform will support even greater growth in this market.”

The AtriClip FLEX-Mini, the smallest surgical LAA device available in the market, incorporates the trusted elements of the AtriClip portfolio, featuring a fully enclosed design with parallel beams for continuous closing force, ensuring optimal pressure on atrial tissue. The low-profile design enhances visibility without compromising stability, providing physicians with unprecedented control during procedures. Additionally, the device's ergonomic handle design enables single-handed placement, further simplifying the application process.

“The AtriClip FLEX-Mini is a significant step forward in ensuring patients receive the best possible treatment,” said Dr. Ibrahim S. Sultan, MD, Professor and Chief, Division of Cardiac Surgery, University of Pittsburgh Medical Center. “This device builds off the first- and second-generation platforms, which established an incredible record of clinical outcomes. With surgical LAA management now having the highest-level recommendation for treatment from multiple physician societies, this new technology will make it even easier for my surgeon colleagues to choose mechanical appendage closure.”

For more information about the AtriClip line of products, visit our website at www.atricure.com/laa-exclusion

Forward-Looking Statements

This press release contains “forward-looking statements”– that is, statements related to future events that by their nature address matters that are uncertain. Actual results could differ materially. For details on the uncertainties that may cause our actual results to be materially different than those expressed in our forward-looking statements, visit http://www.atricure.com/forward-looking-statements as well as our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q which contain risk factors. We assume no obligation to update any forward-looking statements contained in this release and the related attachment as a result of new information or future events or developments, except as may be required by law.

About AtriCure

AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 37 million people worldwide. Electrophysiologists, cardiothoracic and thoracic surgeons around the globe use AtriCure technologies for the treatment of Afib, reduction of Afib related complications and post-operative pain management. AtriCure’s Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure’s Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure’s cryoICE cryoSPHERE® probes are cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240827359775/en/

Angie Wirick

Investor Relations

Chief Financial Officer

(513) 755-5334

awirick@atricure.com

Valerie Storch-Willhaus

Media Relations

Vice President, Corporate Marketing & Communications

(612) 605-3311

vstorch-willhaus@atricure.com

Source: AtriCure, Inc.

FAQ

What is the AtriClip® FLEX-Mini™ device by AtriCure (ATRC)?

The AtriClip® FLEX-Mini™ is AtriCure's newest and smallest profile surgical left atrial appendage (LAA) device, designed for enhanced access and visibility during procedures to treat atrial fibrillation and manage post-operative pain.

When did AtriCure (ATRC) receive 510(k) clearance for the AtriClip FLEX-Mini?

AtriCure received 510(k) clearance for the AtriClip FLEX-Mini recently, as announced in their press release. The exact date was not specified.

How many AtriClip devices has AtriCure (ATRC) sold globally?

According to the press release, AtriCure has sold nearly 600,000 AtriClip devices globally, demonstrating their significant market presence in surgical LAA management.

What are the key features of AtriCure's (ATRC) AtriClip FLEX-Mini device?

The AtriClip FLEX-Mini features a low-profile design for improved visibility, an ergonomic handle for single-handed placement, and parallel beams for continuous closing force, ensuring optimal pressure on atrial tissue.