AtriCure's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by AtriCure (ATRC).
Over the past two years, AtriCure has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
LeAAPS. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
LeAAPS FDA Regulatory Events
LeAAPS is a drug developed by AtriCure for the following indication: For Stroke Prevention.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LeAAPS
- Announced Date:
- July 15, 2025
- Indication:
- For Stroke Prevention
Announcement
AtriCure, Inc announced the completion of enrollment in the left atrial appendage exclusion for prophylactic stroke reduction (LeAAPS) clinical trial (NCT05478304). Initiated in January 2023, LeAAPS enrolled 6,500 patients across 137 centers globally.
AI Summary
AtriCure, Inc announced the completion of enrollment in its LeAAPS clinical trial (NCT05478304), a major step toward understanding how to prevent strokes in cardiac surgery patients without a prior Afib diagnosis. Launched in January 2023, the trial successfully enrolled 6,500 patients at 137 centers worldwide, making it one of the largest studies of its kind. The trial is designed to evaluate the AtriClip device’s ability to reduce the risk of ischemic stroke and systemic arterial embolism in high-risk patients undergoing planned cardiac surgery. With plans for five years of follow-up, the study aims to provide clear evidence that could shape future treatment guidelines and improve long-term patient outcomes in a large, often underserved, cardiac surgery population.
Read Announcement
AtriCure FDA Events - Frequently Asked Questions
As of now, AtriCure (ATRC) has not received any FDA approvals for its therapy in the last two years.
In the past two years, AtriCure (ATRC) has reported FDA regulatory activity for LeAAPS.
The most recent FDA-related event for AtriCure occurred on July 15, 2025, involving LeAAPS. The update was categorized as "Enrollment Completion," with the company reporting: "AtriCure, Inc announced the completion of enrollment in the left atrial appendage exclusion for prophylactic stroke reduction (LeAAPS) clinical trial (NCT05478304). Initiated in January 2023, LeAAPS enrolled 6,500 patients across 137 centers globally."
Currently, AtriCure has one therapy (LeAAPS) targeting the following condition: For Stroke Prevention.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:ATRC) was last updated on 7/20/2025 by MarketBeat.com Staff
