AtriCure has received US Food and Drug Administration (FDA) clearance for its Synergy ablation system, used to treat persistent and long-standing persistent atrial fibrillation during open-heart concomitant coronary artery bypass grafting and valve replacement or repair procedures.
The initiative follows results from a 350-patient post-approval study, of which 46 were been enrolled through the ABLATE study, and a physician training programme.
The Synergy ablation system includes AtriCure’s Isolator Synergy clamps, a radiofrequency generator and related switchbox, which was approved in the US for cardiac tissue ablation during concomitant open-heart surgical procedures.
AtriCure president and CEO David Drachman said the approval supports the effectiveness of the Synergy ablation system and recognises the increasing need for the surgical treatment of atrial fibrillation.
"We look forward to educating physicians and patients on our surgical alternative for the treatment of atrial fibrillation, which we believe will raise awareness for a large number of AF patients that are currently being undertreated,” Drachman said.
”Importantly, we would like to thank all of our partners who worked with us to achieve this approval, particularly the FDA, physicians and their patients who participated in the ABLATE trial."
AtriCure develops, manufactures and sells innovative cardiac surgical ablation systems designed to create precise lesions, or scars, in cardiac, or heart, tissue for the treatment of atrial fibrillation and systems for the exclusion of the left atrial appendage.
Atrial fibrillation affects more than 5.5 million people worldwide, and predisposes them to a five-fold increased risk of stroke.
The company’s other products are not approved in the US for the treatment of other forms of atrial fibrillation, for other uses in the treatment of atrial fibrillation, or to reduce the risk of stroke.