AtriCure Receives Expanded CE-Mark Indication for AtriClip® Devices for the Reduction of Stroke in Patients with Atrial Fibrillation

Rhea-AI Summary

AtriCure, Inc. (Nasdaq: ATRC) has received an expanded CE-Mark indication for its AtriClip® devices in Europe. The devices are now indicated for use in patients at high risk of thromboembolism for whom left atrial appendage (LAA) exclusion is warranted. This expansion is based on substantial clinical evidence demonstrating a reduction in stroke events for patients receiving an AtriClip device.

The AtriClip family of devices are designed to exclude, electrically isolate, and eliminate the LAA during cardiac surgery. With over 550,000 patients treated worldwide, AtriCure has observed significant impact on patient care. The expanded indication confirms clinical evidence that strokes can be reduced in high-risk patients. Over 85 peer-reviewed studies involving more than 11,000 patients have been published on the safety and efficacy of AtriClip devices since 2007.

Positive

• Expanded CE-Mark indication for AtriClip devices in Europe
• Indication now includes high-risk thromboembolism patients
• Clinical evidence shows reduction in stroke events for AtriClip recipients
• Over 550,000 patients successfully treated worldwide
• 85+ peer-reviewed studies published on safety and efficacy
• Studies involve over 11,000 patients across multiple geographies

Negative

• None.

Insights

Medical Research Analyst

The expanded CE-Mark indication for AtriCure's AtriClip® devices is a significant development in stroke prevention for atrial fibrillation patients. This approval, based on extensive clinical evidence, potentially broadens the market for AtriClip in Europe. With 550,000 patients treated globally, the device has demonstrated its efficacy in reducing stroke events in high-risk thromboembolism patients.

The robust clinical backing, including over 85 peer-reviewed studies covering 11,000+ patients, strengthens AtriClip's position in the market. This expanded indication could drive adoption rates among cardiac surgeons, potentially leading to increased revenue for AtriCure in the European market.

Financial Analyst

This regulatory win for AtriCure (NASDAQ: ATRC) is likely to have a positive impact on the company's financial outlook. The expanded indication in CE-marked countries opens up a larger addressable market, potentially driving sales growth in Europe. With 550,000 patients treated worldwide, AtriClip has already demonstrated significant market penetration.

Investors should note that this approval could lead to increased adoption rates among surgeons, potentially boosting AtriCure's revenue streams. However, it's important to monitor how quickly this translates into actual sales growth and market share gains in the coming quarters.

Cardiology Expert

The expanded CE-Mark indication for AtriClip® is a game-changer in stroke prevention for atrial fibrillation patients. Left atrial appendage (LAA) exclusion is a critical strategy in reducing stroke risk and AtriClip's proven efficacy in this area is now officially recognized. This device offers a mechanical solution to LAA closure, which can be particularly beneficial for patients who cannot tolerate long-term anticoagulation therapy.

The device's ability to electrically isolate and eliminate the LAA addresses a major source of blood clots in Afib patients. This expanded indication could lead to more widespread adoption of LAA exclusion procedures, potentially improving outcomes for high-risk patients across Europe.

Expanded indication based on an abundance of clinical evidence for AtriClip Devices

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 it has received an expanded indication for the AtriClip^® in CE-marked countries in Europe. The product is now indicated for use in patients at high risk of thromboembolism for whom left atrial appendage exclusion is warranted.

The AtriClip family of devices are innovative solutions designed to exclude, electrically isolate, and eventually eliminate the left atrial appendage during cardiac surgery. The LAA is a major source of blood clots in patients with Afib, and this expanded indication is a result of a significant body of clinical evidence and real-world experience that demonstrates a reduction in stroke events for patients who receive an AtriClip device.

“This new indication is tremendous validation of our AtriClip device,” said Michael Carrel, President and CEO of AtriCure. “With over 550,000 patients successfully treated worldwide, we have seen the impact that our devices have on patient care. The expanded indication from the European Commission confirms our own clinical evidence that strokes can be reduced in patients who are at high risk of developing thromboembolism, and we continue to see strong opportunity to grow adoption of mechanical appendage closure.”

Since the first AtriClip device was used in 2007, there have been over 85 peer-reviewed studies published on both acute and long-term safety and efficacy. This represents over 11,000 patients who were studied across multiple geographies.

“I’ve been using AtriClip devices for over a decade and have seen firsthand the benefits of its safety and efficacy,” said Professor Dr. Med. Nicolas Doll, Chief Physician of Cardiac Surgery, Schuechtermann-Clinic, Bad Rothenfelde, Germany. “The devices are easy to use, and they provide patients with the benefit of long-term prevention of stroke, which makes adoption of the AtriClip an easy decision.”

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 X (formerly Twitter) @AtriCure.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240822944439/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 new CE-Mark indication for AtriCure's AtriClip devices?

AtriCure's AtriClip devices have received an expanded CE-Mark indication for use in patients at high risk of thromboembolism for whom left atrial appendage exclusion is warranted in Europe.

How many patients have been treated with AtriClip devices worldwide?

Over 550,000 patients have been successfully treated worldwide with AtriCure's AtriClip devices.

What clinical evidence supports the expanded indication for AtriClip devices?

The expanded indication is supported by over 85 peer-reviewed studies involving more than 11,000 patients, demonstrating a reduction in stroke events for patients receiving an AtriClip device.

When was the first AtriClip device used?

The first AtriClip device was used in 2007, and since then, numerous studies have been published on its safety and efficacy.

What is the primary benefit of AtriClip devices for patients with atrial fibrillation?

The primary benefit of AtriClip devices for patients with atrial fibrillation is the long-term prevention of stroke by excluding the left atrial appendage, which is a major source of blood clots in these patients.