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AtriCure Announces Successful Completion of Patient Enrollment of aMAZE Clinical Trial and FDA Approval of Continued Access Protocol
MASON, Ohio--(BUSINESS WIRE)-- AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in treatments for atrial fibrillation (Afib) and left atrial appendage
About this update from Atricure, Inc.
[{"type":"text","content":" MASON, Ohio--(BUSINESS WIRE)--\n AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in treatments for\n atrial fibrillation (Afib) and left atrial appendage (LAA) management,\n today announced the successful completion of patient enrollment in the\n aMAZE™ clinical trial. In addition, the company announced that it has\n received approval from the Food and Drug Administration (FDA) for the\n continuation of the trial under a Continued Access Protocol (CAP) with\n an additional patient enrollment of up to 85 patients and the\n opportunity to further expand to 250 patients while the pre-market\n application is under review.\n \n \n The aMAZE trial is an FDA-approved, prospective, multicenter, randomized\n controlled, superiority-designed trial evaluating the LARIAT®\n Suture Delivery Device for LAA exclusion adjunctive to Pulmonary Vein\n Isolation (PVI) catheter ablation for the treatment of persistent and\n long-standing persistent Afib. The objective of the aMAZE trial is to\n demonstrate that the LARIAT device for LAA exclusion, plus PVI ablation,\n will safely and effectively lead to a reduced incidence of recurrent\n Afib compared to PVI alone. The aMAZE trial enrolled 600 total patients\n at 53 sites, and the primary effectiveness endpoint measure is freedom\n from episodes of Afib greater than 30 seconds at one-year post PVI. The\n company anticipates final patient follow-up in 2021 with final\n Pre-Market Approval (PMA) submission later in 2021.\n \n \n “We are pleased that the aMAZE trial has successfully reached the end of\n enrollment,” said Dr. David Wilber, MD, aMAZE trial national\n co-Principal Investigator and Director of the Cardiovascular Institute\n at Loyola University Medical Center. “The pace of enrollment for a\n 600-patient trial was outstanding, and I’m proud of the quality of the\n study execution. Completing this trial is important for changing the\n treatment paradigm for patients with persistent and long-standing\n persistent Afib.”\n \n \n AtriCure also announced that it has received approval from the FDA to\n expand patient enrollment under a Continued Access Protocol. The aMAZE\n trial CAP will allow for ongoing treatment of patients and the\n collection of additional safety and efficacy data while the PMA\n application for the LARIAT System is under review. The CAP incorporates\n a nested, single-...