WEST CHESTER, Ohio--(BUSINESS WIRE)--AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatments for atrial fibrillation (Afib) and left atrial appendage management, today announced it has sold more than 50,000 AtriClip® Left Atrial Appendage Exclusion System devices worldwide, making it not only the preferred surgical device but also the most widely used of all devices for excluding the left atrial appendage (LAA), with more units sold than all other LAA management devices combined.
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.1 Prior to the invention of the AtriClip system, cardiac surgeons typically addressed the LAA during open heart surgery by cutting it off or closing off the opening of LAA to the atrium. This approach required extra time on the heart-lung machine and posed a risk of hemorrhaging and or reopening over time.
“Cardiac Surgeons are increasingly becoming more comfortable with using our device versus the traditional methods of amputation or simply closing the opening with suture or stapling devices,” said Mike Carrel, president and chief executive officer of AtriCure. “We are excited about our prospects for continued significant growth.”
“From my experience, the AtriClip device has provided consistent LAA closure every time,” said Dr. Andrea Natale, Electrophysiologist and Executive Medical Director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center. “I have been working more closely with my cardiac surgeons and recommending that the AtriClip System be used for LAA exclusion.”
The AtriClip System is cleared by the Food and Drug Administration with an indication for occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. The clearance resulted in part from the successful EXCLUDE trial (NCT00779857), which showed the LAA was closed successfully with the AtriClip device in 98.4 percent of patients, with no device-related mortality. 2
"The AtriClip provides surgeons with the speed, ease of delivery and efficacy we need for LAA management," said Dr. Marc Gerdisch, Chief of Cardiovascular and Thoracic Surgery, Franciscan St. Francis Health, Indianapolis. "I have used the device for several years, including minimally invasive procedures, and it has performed perfectly."
In early 2014, AtriCure initiated the Stroke Feasibility Study (NCT01997905) using the AtriClip system in a minimally invasive procedure on a beating heart in seven hospitals across the United States. This study evaluates the safety of the AtriClip system when used for stroke prevention in patients with non-valvular Afib who can’t take long-term anticoagulation medications. Complete exclusion of the LAA will be confirmed during the procedure using echo graphic imaging.
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 management (LAAM) exclusion device is the most widely sold device worldwide that’s indicated for the occlusion of the left atrial appendage. The company believes cardiothoracic surgeons are adopting its ablation and LAAM devices for the treatment of Afib and reduction of Afib related complications such as stroke. Afib affects more than 33 million people worldwide.3 For more information visit AtriCure.com or follow us on Twitter @AtriCure.
1 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.
2Data on file at AtriCure. IDE G080095, EXCLUDE study.
3 Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, et al., “Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study.” Circulation. 2014 Feb 25; 129 (8):837-47.