AtriClip is the most widely used device indicated for left atrial appendage management
WEST CHESTER, Ohio--(BUSINESS WIRE)--Jul. 16, 2014-- AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatments for atrial fibrillation (Afib), today announced that it has sold more than 34,000 AtriClip® Left Atrial Appendage Exclusion System devices worldwide, quickly becoming the top selling device used for eliminating the left atrial appendage (LAA).
The LAA is a muscular pouch attached to the heart's left atrium. In patients with Afib and other cardiac arrhythmias, blood can pool and form clots in the appendage, which may then leave the heart and cause strokes. One study concluded that more than 90 percent of detected blood clots in patients with atrial fibrillation are formed in the LAA.1
Patients who suffer from Afib have a 500 percent greater risk of stroke, compared with the general population.2 Afib-related strokes are associated with higher morbidity and mortality than non-Afib related strokes.3 More than 2.7 million people in the United States, and more than 15 million people worldwide, suffer from Afib.4
For years, heart surgeons would remove the LAA with a cut-and-sew method during surgery, which required extra time on the heart-lung machine and posed a risk of hemorrhaging. The engineering team at AtriCure listened to requests from heart surgeons to develop a device that could be quickly deployed, be reproducible and completely eliminate the LAA.
In 2010, the AtriClip System was cleared for sale in the United States by the Food and Drug Administration with the indication for occlusion of the LAA, under direct visualization, in conjunction with other open cardiac surgical procedures. The clearance was made after the EXCLUDE trial (NCT00779857) showed the LAA was closed successfully with the AtriClip device in 98.4 percent of patients, with no device-related mortality. 1
"The AtriClip device is quick to place and provides consistent occlusion of the appendage with minimal risk of hemorrhage," said Dr. J. Michael Smith, chief of cardiovascular surgery, director of robotics, co-director of transcatheter valve therapies and surgical research director of the Hatton Research Institute at TriHealth in Cincinnati.
In early 2014, AtriCure initiated the Stroke Feasibility Study (NCT01997905) using the AtriClip System in a minimally invasive procedure on a beating heart. This study will evaluate the safely of the AtriClip System when used for stroke prevention in patients with non-valvular atrial fibrillation who can't take long-term anticoagulation medications. Complete exclusion of the LAA will be confirmed during the procedure using echo graphic imaging. The study will be conducted at seven hospitals in the United States, enrolling up to 30 patients.
"This study demonstrates our commitment to developing compelling solutions that improve patients' lives and decrease the social and economic burden of atrial fibrillation," said Mike Carrel, chief executive officer of AtriCure. "The previous difficulty in obtaining complete appendage closure has largely been overcome with the use of the AtriClip System."
AtriCure, Inc. is a medical device company providing innovative atrial fibrillation (Afib) solutions designed to produce superior outcomes that reduce the economic and social burden of atrial fibrillation. AtriCure's Synergy™ Ablation System is the first and only surgical device approved for the treatment of Persistent and Longstanding Persistent forms of Afib in patients undergoing certain open concomitant procedures. AtriCure's AtriClip Left Atrial Appendage (LAA) exclusion device is the most widely sold device worldwide that's indicated for the occlusion of the LAA. The company believes cardiothoracic surgeons are adopting its ablation and LAA management devices for the treatment of Afib and reduction of Afib related complications such as stroke. Afib affects more than 5.5 million people worldwide.
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 (including projections and guidance), 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, AtriCure's ability to consummate acquisitions or, if consummated, to successfully integrate acquired businesses into AtriCure's operations, AtriCure's ability to recognize the benefits of acquisitions, including potential synergies and cost savings, failure of an acquisition or acquired company to achieve its plans and objectives generally, risk that proposed or consummated acquisitions may disrupt operations or pose difficulties in employee retention or otherwise affect financial or operating results, 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.
1 Jeff S. Healey, MD,Eugene Crystal, MD, Andrew Lamy, , et al. Left Atrial Appendage Occlusion Study (LAAOS): Results of a randomized controlled pilot study of left atrial appendage occlusion during coronary bypass surgery in patients at risk for stroke. American Heart Journal. 2005 Aug; 150:288-93.
2 Benjamin EJ, Chen PS, Bild DE, et al. Prevention of atrial fibrillation: report from a national heart, lung, and blood institute workshop. Circulation. 2009 Feb 3; 119(4):606-18.
3 Marini C, De Santis F, Sacco S, et al. Contribution of atrial fibrillation to incidence and outcome of ischemic stroke: results from a population-based study. Stroke. 2005 Jun;36(6):1115-9.
4. United States Centers for Disease Control.
5. Ailawadi G, Gerdisch MW, Harvey RL, Hooker RL, Damiano RJJ, Salamon T, et al. Exclusion of the left atrial appendage with a novel device: early results of a multicenter trial. J Thorac Cardiovasc Surg. 2011;142:1002-9.