AtriCure, Inc. is a medical device company focused on developing, manufacturing, and selling innovative surgical devices to create precise lesions, or scars, in soft tissues. Medical journals have described the adoption by leading cardiothoracic surgeons of the AtriCure bipolar ablation system as a standard treatment alternative during open-heart surgical procedures to safely, rapidly, and reliably create lesions in cardiac, or heart, tissue to block the abnormal electrical impulses that cause atrial fibrillation (AF), a rapid, irregular quivering of the upper chambers of the heart. Some leading cardiothoracic surgeons have also begun using the system as a sole-therapy minimally invasive treatment for AF. The general commercial release of this system in the U.S. was in January 2003. AtriCure's business and future growth depend on the continued use of the bipolar ablation system in the treatment of AF, which is considered an off-label use of the system because the indications for which the system has received the U.S. Food & Drug Administration (FDA) clearance or approval is the ablation and coagulation of soft tissues during certain non-cardiac-related surgical procedures and the ablation of cardiac tissue. AtriCure consummated an initial public offering of its common stock on August 10, 2005.
In addition to the bipolar ablation system, AtriCure products include the Isolator pen, the Wolf dissector, and an ablation device that uses cryothermy, or extreme cold, to ablate tissues. The AtriCure bipolar ablation system consists of the ablation and sensing unit (ASU) and a series of uniquely designed disposable Isolator handpieces. The ASU is a compact power generator that uses AtriCure's proprietary software and delivers bipolar radio-frequency energy. The pen-shaped ablation device has been cleared by the FDA for the surgical ablation of cardiac tissue and for temporary pacing, sensing, stimulating, and recording during the evaluation of cardiac arrhythmias. The product is well suited to be used in connection with AtriCure's system to create transmural lesions in difficult-to-reach cardiac tissue. The Wolf dissector is cleared by the FDA for use on thoracic and certain other non-cardiac soft tissues. This dissection tool is used by surgeons to separate tissues surrounding the heart to provide access to key anatomical structures that are targeted for ablation during sole-therapy minimally invasive AF treatments. A dissection tool for the open procedure was released in early 2007. In 2006, domestic open heart, domestic minimally invasive sole-therapy (MIS), and international contributed 60%, 29%, and 11%, respectively to total revenue. The isolator bipolar pen has been divided between the minimally invasive and open-heart products.