AtriCure (ATRC) FDA Approvals $28.86 +0.07 (+0.24%) As of 11:16 AM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock AtriCure's Drug in the FDA Approval ProcessThis 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. Enrollment Completion - July 15,2025Enrollment Completion Drug: LeAAPSAnnounced Date: July 15, 2025Indication: For Stroke PreventionAnnouncementAtriCure, 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 SummaryAtriCure, 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 Has AtriCure received FDA approval? As of now, AtriCure (ATRC) has not received any FDA approvals for its therapy in the last two years. What drugs has AtriCure submitted to the FDA? In the past two years, AtriCure (ATRC) has reported FDA regulatory activity for LeAAPS. What is the most recent FDA event for AtriCure? 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." What conditions do AtriCure's current drugs treat? Currently, AtriCure has one therapy (LeAAPS) targeting the following condition: For Stroke Prevention. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Medicus Pharma FDA EventsPrecigen FDA EventsBioCryst Pharmaceuticals FDA EventsCogent Biosciences FDA EventsJazz Pharmaceuticals FDA EventsKymera Therapeutics FDA EventsAbbVie FDA EventsAC Immune FDA EventsAscendis Pharma A/S FDA EventsC4 Therapeutics FDA EventsCompugen FDA EventsCellectis FDA EventsClimb Bio FDA EventsCaribou Biosciences FDA EventsAlpha Tau Medical FDA Events 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 Related Companies AngioDynamics FDA Events Medtronic FDA Events Boston Scientific FDA Events Becton, Dickinson and Company FDA Events DexCom FDA Events Insulet FDA Events Teleflex FDA Events Haemonetics FDA Events Capricor Therapeutics FDA Events QuidelOrtho FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:ATRC last updated on 7/15/2025 by MarketBeat.com Staff. 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Enrollment Completion - July 15,2025Enrollment Completion Drug: LeAAPSAnnounced Date: July 15, 2025Indication: For Stroke PreventionAnnouncementAtriCure, 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 SummaryAtriCure, 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
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