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AtriCure Receives FDA Approval for Investigational Study to Evaluate Stroke Prevention in Atrial Fibrillation

November 19, 2013  |  AtriCure Receives FDA Approval for Investigational Study
Atricure

The Wall Street Journal, MarketWatch

WEST CHESTER, Ohio, Nov 19, 2013 (BUSINESS WIRE) -- AtriCure, Inc., a leading developer of solutions to treat atrial fibrillation (Afib), today announced the Food and Drug Administration's (FDA) approval to begin enrollment in a clinical study of AtriCure's AtriClip(R) Left Atrial Appendage Exclusion System. The study will evaluate the use of the AtriClip device to prevent stroke in patients with Afib.

The feasibility study will enroll Afib patients at seven medical centers across the country. The study will focus on patients with risk factors that place them at significant risk of stroke as well as substantial bleeding risks that contraindicate them for anticoagulation therapy. Research suggests that up to 40% of patients are unable to take oral anticoagulants due to excessive risk of bleeding.(1)

Patients with Afib have a 500 percent increased risk of stroke over the general public.(2) Afib related strokes are associated with higher morbidity and mortality than non-Afib related strokes.(3) Since the left atrial appendage (LAA), a muscular pouch attached to the heart, has been found to be the source of approximately 90% of thrombi in Afib patients evaluated after a confirmed stroke, this study will focus on complete and permanent mechanical closure of the LAA.(4)

During the feasibility study, patients will undergo a minimally invasive surgical procedure. Utilizing small incisions in the chest wall surgeons will place the AtriClip device directly onto the base of the LAA while the heart is still beating. Complete exclusion of the LAA is confirmed during the procedure using echo graphic imaging. Three months following the procedure, a computerized tomography (CT) scan will be performed to re-confirm complete and permanent LAA exclusion on all patients.

The AtriClip LAA Exclusion System is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. AtriCure received FDA 510(k) clearance for the AtriClip device in June 2010 based upon the successful results of the EXCLUDE trial (#G080095). In this study, complete and permanent exclusion of the LAA was confirmed in 98.4% of patients by a three month post procedure CT scan with zero complications or adverse events. Since launch, more than 25,000 AtriClips have been implanted worldwide.

"Managing high risk Afib patients requires balancing the risk of stroke against the risk of major bleeding," said Dr. Basel Ramlawi, a cardiothoracic surgeon at Houston Methodist DeBakey Heart Center and the Principal Investigator in the study. "This study is a major step toward developing the clinical evidence necessary to establish a viable, safe and attractive alternative to life-long anticoagulation in Afib patients that currently have very limited options. This will have a favorable impact on patients and the healthcare system overall."

"The Stroke Feasibility IDE study is significant because it is the first of its kind to focus entirely on a group of untreated and undertreated Afib patients that may benefit the most from total and permanent exclusion of their left atrial appendage," said Michael Carrel, President and Chief Executive Officer of AtriCure. "This study is one of three FDA trials that AtriCure is currently running as part of our strategy to be the leader in developing proven and effective solutions for the worldwide Afib epidemic."

About AtriCure, Inc. AtriCure, Inc. is a leading atrial fibrillation (Afib) solutions partner, providing innovative products, industry education and clinical science investment to reduce the economic and social burden of atrial fibrillation. AtriCure's Synergy Ablation System is the first and only device approved by the Food and Drug Administration (FDA) for the treatment of Persistent and Longstanding Persistent forms of Afib in patients undergoing certain open heart procedures concomitantly (simultaneously). AtriCure's AtriClip Left Atrial Appendage (LAA) exclusion device is the most widely implanted device for LAA management worldwide. The company believes cardiothoracic surgeons are adopting its ablation and LAA management devices for the treatment of Afib and prevention of Afib related complications such as stroke.

Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that address activities, events or developments that AtriCure expects, believes or anticipates will or may occur in the future, such as earnings estimates, other predictions of financial performance, launches by AtriCure of new products and market acceptance of AtriCure's products. Forward-looking statements are based on AtriCure's experience and perception of current conditions, trends, expected future developments and other factors it believes are appropriate under the circumstances and are subject to numerous risks and uncertainties, many of which are beyond AtriCure's control. These risks and uncertainties include the rate and degree of market acceptance of AtriCure's products, AtriCure's ability to develop and market new and enhanced products, the timing of and ability to obtain and maintain regulatory clearances and approvals for its products, the timing of and ability to obtain reimbursement of procedures utilizing AtriCure's products, competition from existing and new products and procedures or AtriCure's ability to effectively react to other risks and uncertainties described from time to time in AtriCure's SEC filings, such as fluctuation of quarterly financial results, reliance on third party manufacturers and suppliers, litigation or other proceedings, government regulation and stock price volatility. AtriCure does not guarantee any forward-looking statement, and actual results may differ materially from those projected. AtriCure undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

SOURCE: AtriCure, Inc.

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