The CRyoanalgesia REgistry for Pain Management in PostcarDiothoracic SUrgery Via Cryoablation of the intercostal nErves (REDUCE Registry), RP-2018-REDUCE - REDUCE

开始日期2026-02-20

申办/合作机构

AtriCure, Inc.

NCT07281118

/ RecruitingN/AIIT

Intercostal Cryoanalgesia in Double Lung Transplant Recipients

This study is testing a new way to help manage pain after a double lung transplant. Instead of relying only on strong pain medicines like opioids, doctors will use a cold-therapy probe during surgery to help numb the nerves near the incision. Researchers want to see if this method can reduce the need for opioids and improve recovery.

开始日期2025-12-16

申办/合作机构

University of California, Los Angeles

[+1]

ACTRN12625000778482

/ RecruitingN/A

First-In-Human Study to evaluate the safety and feasibility of EnCompass-S2 ARFA PFA Dual Energy Clamp in patients undergoing cardiac ablation during a concomitant cardiac surgical procedure. (EnCompass-S2 FIH)

开始日期2025-11-10

申办/合作机构

AtriCure, Inc.

100 项与 AtriCure, Inc. 相关的临床结果

登录后查看更多信息

0 项与 AtriCure, Inc. 相关的专利（医药）

登录后查看更多信息

项与 AtriCure, Inc. 相关的文献（医药）

2025-10-01·Circulation-Arrhythmia and Electrophysiology

Dual Epicardial and Endocardial Procedure (DEEP) for Persistent or Longstanding Persistent Atrial Fibrillation

Article

作者: Hoff, Steven J. ; Frazier, Ken ; Kang, Steven ; Kasirajan, Vigneshwar ; Vesco, Paul A. ; La Meir, Mark ; Link, Michael G. ; Eisenberg, Susan ; Lee, Mark Y. ; de Asmundis, Carlo ; Lee, Randall J. ; Koneru, Jayanthi N. ; Johnkoski, John ; Mumtaz, Mubashir ; Miles, William M. ; Rist, Kevin ; Beaver, Thomas M. ; Badhwar, Nitish ; Smith, J. Michael ; Lee, Anson M. ; Khoynezhad, Ali ; Khan, Junaid H. ; Vloka, Margot ; Jones, Stephen D. ; Okum, Eric J. ; Ellenbogen, Kenneth A. ; Baykaner, Tina ; de Groot, Joris R. ; Philpott, Jonathan M. ; Taylor, Benedict J. ; Gaynor, Sydney ; Driessen, Antoine H.G. ; Gandhi, Gaurang D. ; Dunnington, Gansevoort ; Bello, David

BACKGROUND::

Despite advances in endocardial catheter ablation (ECA) for persistent atrial fibrillation (PersAF), undertreatment persists, especially in ECA nonresponders and in longstanding PersAF (LSPersAF), with disappointing ablation results. These patients need effective clinical treatment options.

METHODS::

The DEEP (Dual Epicardial and Endocardial Procedure) was a prospective, multicenter, single-arm, investigational device exemption trial to establish the safety and effectiveness of a combined epicardial/endocardial ablation procedure with left atrial appendage exclusion for PersAF/LSPersAF. Eligibility included age 18 to 75 years; symptomatic PersAF/LSPersAF refractory to ≥1 Class I/III antiarrhythmic drug; and ≤2 previous failed ECAs. Two-stage hybrid ablation included ECA performed at 91 to 121 days after the epicardial first stage (including left atrial appendage exclusion), followed by a 90-day blanking and 90-day antiarrhythmic drug optimization period. Primary effectiveness was defined as freedom from documented atrial fibrillation/atrial flutter/atrial tachycardia episodes >30 seconds through the 12-month follow-up, absent Class I/III antiarrhythmic drugs, except previously failed antiarrhythmic drugs at doses not exceeding those previously failed. Primary safety was defined as a composite of device/procedure-related serious adverse events within 30 days of epicardial ablation and 7 days of ECA.

RESULTS::

Ninety patients enrolled from February 2015 to December 2020; 83.3% (75/90) were male and mean±SD age was 63.4±7.7 years. AF classification was 83.3% (75/90) PersAF/16.7% (15/90) LSPersAF, and 47.8% (43/90) had prior ECA. The composite serious adverse events rate was 6.7% (6/90 [95% CI, 2.5%–13.9%]; P <0.001 versus safety goal), including 3 patients experiencing serious adverse events within 30 days of the epicardial procedure and 3 patients within 7 days of the endocardial procedure, all of whom were anticoagulated at the time of the event. Primary effectiveness through 12 months was 71.8% (61/85 [95% CI, 62.2%–81.3%]; P =0.0134 versus performance goal) and was 62.4% (53/85 [95% CI, 52.1%–72.7%]) through 2 years.

CONCLUSIONS::

A collaborative hybrid ablation approach to treating PersAF/LSPersAF is safe and effective.

REGISTRATION::

URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02393885.

2025-06-01·AMERICAN HEART JOURNAL

The left atrial appendage exclusion for prophylactic stroke reduction (LEAAPS) trial: Rationale and design

Article

作者: Whitlock, Richard P. ; Rose, David Z ; Belley-Côté, Emilie P ; Ramlawi, Basel ; Connolly, Stuart J. ; Healey, Jeffrey S ; Alexander, John H ; Connolly, Stuart J ; Rose, David Z. ; Whitlock, Richard P ; Sultan, Ibrahim ; Gerdisch, Marc W ; McCarthy, Patrick M. ; Belley-Côté, Emilie P. ; Gerdisch, Marc W. ; Alexander, John H. ; Sharma, Yashasvi Awasthi ; McCarthy, Patrick M ; Sharma, Yashasvi Awasthi ; Healey, Jeffrey S.

INTRODUCTION:

Left atrial appendage exclusion (LAAE) has been shown in randomized trials to reduce ischemic stroke risk in patients undergoing cardiac surgery with known atrial fibrillation (AF). Many patients undergoing cardiac surgery without pre-existing AF are at risk of stroke and may benefit from LAAE.

METHODS:

Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction (LeAAPS) is an international, prospective, randomized, multicenter, blinded trial evaluating the effectiveness of LAAE in preventing ischemic stroke or systemic embolism in patients undergoing cardiac surgery at increased risk of AF and ischemic stroke. The trial will enroll 6500 patients at increased risk of stroke in whom a cardiac surgery is planned at 250 sites worldwide. Eligible patients are ≥18 years old, have no pre-existing AF but are at increased risk for AF and stroke (based on age, CHA₂DS₂-VASc score, left atrium size or brain natriuretic peptide). Patients are randomized 1:1 to receive either LAAE with AtriClip or no LAAE during cardiac surgery. Healthcare providers outside of the operating room and the patient will be blinded to allocation. The primary effectiveness endpoint is the first occurrence of ischemic stroke, systemic arterial embolism, or surgical or endovascular LAA closure. The powered secondary effectiveness endpoint is ischemic stroke or systemic arterial embolism. The primary safety endpoint is the occurrence of one of the following events (through 30 days): pericardial effusion requiring percutaneous or surgical treatment, peri-operative major bleeding, deep sternal wound infection, or myocardial infarction. Other endpoints include mortality, rehospitalizations, clinically diagnosed AF, transient ischemic attack, and cognitive and quality of life assessments. Follow-up is every 6 months for a minimum of 5 years; primary analysis occurs when 469 patients have had an ischemic stroke or systemic embolism.

CONCLUSION:

The results of the LeAAPS trial will demonstrate whether LAAE with AtriClip at the time of other routine cardiac surgery reduces stroke or systemic arterial embolism during long-term follow-up in patients at high risk of stroke without pre-existing AF.

TRIAL REGISTRATION:

ClinicalTrials.gov, Identifier: NCT05478304, https://clinicaltrials.gov/study/NCT05478304?term=%20NCT05478304&rank=1.

2024-04-02·JAMA

Pulmonary Vein Isolation With or Without Left Atrial Appendage Ligation in Atrial Fibrillation

Article

作者: Evonich, Rudy ; Yakubov, Steven J. ; Calkins, Hugh ; Hoskins, Michael H. ; Lakkireddy, Dhanunjaya R. ; Hounshell, Troy ; Lee, Randall J. ; Horton, Rodney ; Simons, Pamela ; Berger, Ronald D. ; Wilber, David J. ; Ellis, Christopher R. ; Chandhok, Sheetal ; Tschopp, David ; Mittal, Suneet ; Saville, Benjamin R. ; Rasekh, Abdi

Importance:

Left atrial appendage elimination may improve catheter ablation outcomes for atrial fibrillation.

Objective:

To assess the safety and effectiveness of percutaneous left atrial appendage ligation adjunctive to catheter pulmonary vein isolation for nonparoxysmal atrial fibrillation.

Design, Setting, and Participants:

This multicenter, prospective, open-label, randomized clinical trial evaluated the safety and effectiveness of percutaneous left atrial appendage ligation adjunctive to planned pulmonary vein isolation for nonparoxysmal atrial fibrillation present for less than 3 years. Eligible patients were randomized in a 2:1 ratio to undergo left atrial appendage ligation and pulmonary vein isolation or pulmonary vein isolation alone. Use of a 2:1 randomization ratio was intended to provide more device experience and safety data. Patients were enrolled from October 2015 to December 2019 at 53 US sites, with the final follow-up visit on April 21, 2021.

Interventions:

Left atrial appendage ligation plus pulmonary vein isolation compared with pulmonary vein isolation alone.

Main Outcomes and Measures:

A bayesian adaptive analysis was used for primary end points. Primary effectiveness was freedom from documented atrial arrythmias of greater than 30 seconds duration 12 months after undergoing pulmonary vein isolation. Rhythm was assessed by Holter monitoring at 6 and 12 months after pulmonary vein isolation, symptomatic event monitoring, or any electrocardiographic tracing obtained through 12 months after pulmonary vein isolation. Primary safety was a composite of predefined serious adverse events compared with a prespecified 10% performance goal 30 days after the procedure. Left atrial appendage closure was evaluated through 12 months after pulmonary vein isolation.

Results:

Overall, 404 patients were randomized to undergo left atrial appendage ligation plus pulmonary vein isolation and 206 were randomized to undergo pulmonary vein isolation alone. Primary effectiveness was 64.3% with left atrial appendage ligation and pulmonary vein isolation and 59.9% with pulmonary vein isolation only (difference, 4.3% [bayesian 95% credible interval, −4.2% to 13.2%]; posterior superiority probability, 0.835), which did not meet the statistical criterion to establish superiority (0.977). Primary safety was met, with a 30-day serious adverse event rate of 3.4% (bayesian 95% credible interval, 2.0% to 5.0%; posterior probability, 1.0) which was less than the prespecified threshold of 10%. At 12 months after pulmonary vein isolation, complete left atrial appendage closure (0 mm residual communication) was observed in 84% of patients and less than or equal to 5 mm residual communication was observed in 99% of patients.

Conclusions and Relevance:

Percutaneous left atrial appendage ligation adjunctive to pulmonary vein isolation did not meet prespecified efficacy criteria for freedom from atrial arrhythmias at 12 months compared with pulmonary vein isolation alone for patients with nonparoxysmal atrial fibrillation, but met prespecified safety criteria and demonstrated high rates of closure at 12 months.

Trial Registration:

ClinicalTrials.gov Identifier: NCT02513797

108

项与 AtriCure, Inc. 相关的新闻（医药）

2026-04-28

·Business Wire

AtriCure to Participate in the 2026 Bank of America Securities Health Care Conference

MASON, Ohio--(BUSINESS WIRE)--AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatments and therapies for atrial fibrillation (Afib), left atrial appendage (LAA) management, and post-operative pain management, today announced that the company will be participating in the upcoming 2026 Bank of America Securities Health Care Conference. AtriCure’s management is scheduled to participate in a fireside chat on Tuesday, May 12, 2026, at 10:00 a.m. Pacific Daylight Time. Interested parties may access a live audio webcast by visiting the “Investors” section of the company’s website at https://ir.atricure.com. About AtriCure AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 59 million people worldwide. Surgeons around the globe use AtriCure technologies for the treatment of Afib, reduction of Afib related complications and post-operative pain management. AtriCure’s Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure’s Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure’s cryoICE cryoSPHERE® and cryoXT® probes are cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac, thoracic and amputation procedures. For more information, visit AtriCure.com or follow us on X @AtriCure.

上市批准

2026-04-15

·BioSpace

AtriCure to Announce First Quarter 2026 Financial Results

MASON, Ohio--(BUSINESS WIRE)-- AtriCure, Inc. ( Nasdaq: ATRC ), a leading innovator in surgical treatments and therapies for atrial fibrillation (Afib), left atrial appendage (LAA) management, and post-operative pain management, today announced that it will release its first quarter 2026 financial results on Tuesday, May 5, 2026. AtriCure will host an audio webcast at 4:30 p.m. Eastern Time on Tuesday, May 5, 2026, to discuss its first quarter financial results. Those interested in listening to the conference call should register online using this link . Participants are encouraged to register more than 15 minutes before the start of the call. A live and replay version of the audio webcast will be available at . About AtriCure AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 59 million people worldwide. Surgeons around the globe use AtriCure technologies for the treatment of Afib, reduction of Afib related complications and post-operative pain management. AtriCure’s Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure’s Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure’s cryoICE cryoSPHERE® and cryoXT® probes are cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac, thoracic and amputation procedures. For more information, visit AtriCure.com or follow us on X @AtriCure. Contacts Angie Wirick AtriCure, Inc. Chief Financial Officer (513) 755-5334 awirick@atricure.com Marissa Bych Gilmartin Group Investor Relations marissa@gilmartinir.com

财报

2026-02-23

·MDDI Online

Cardiology Leads Earnings for 4 Medtech Powerhouses

Cardiology is emerging as the medical device segment to watch in 2026, with several recent earnings calls highlighting its momentum across the industry. The cardiac space saw rapid transformation in 2025, from the dominant reign of PFA offerings, to a growing interest in TAVR procedures . Now, four major medtech companies are crediting their recent financial success to strong performance in cardiac segments. Edwards Lifesciences Edwards Lifesciences had a monumental Q4 and full year 2025, growing sales 13.3% to $1.57 billion in the last quarter of the year. The company credited TAVR and TMTT performance for driving these financial gains. In Q4, TAVR sales grew 12.0% to $1.16 billion 1, while TMTT sales grew more than 40% to $156 million from repair and replacement therapies. Full-year TAVR 2025 global sales of $4.5 billion increased 8.6% year-over-year on a constant currency basis. In the U.S., the company saw intentional and urgent treatment of patients with severe aortic stenosis, fueled by a large and growing body of positive evidence on the SAPIEN platform. In May 2025, Edwards won a nod from FDA to approve the Sapien 3 platform, a transcatheter aortic valve replacement therapy to treat patients without symptoms, suffering from severe aortic stenosis. This was the first time FDA approved TAVR for asymptomatic patients. The Sapien 3 platform (Sapien 3, Sapien 3 Ultra, and Sapien 3 Ultra Resilia) has been approved based on data from the EARLY TAVR trial, which demonstrated that asymptomatic severe AS patients randomized to Edwards TAVR experienced superior outcomes compared to guideline-recommended clinical surveillance (watchful waiting). In April, the company secured a CE mark for the Sapien M3 mitral valve. The approval was for the transcatheter treatment of patients with symptomatic (moderate-to-severe or severe) mitral regurgitation (MR) who are deemed unsuitable for surgery or transcatheter edge-to-edge (TEER) therapy. ArtiCure Mason, Ohio-based AtriCure, a specialist in surgical treatments and therapies for atrial fibrillation, left atrial appendage management, and post-operative pain management, saw substantial revenue growth in Q4 2025 . The company saw a 13.1% year-over-year growth for the quarter, reaching worldwide revenues of $140.5 million. Full year 2025 worldwide revenue reached $534.5 million, an increase of 14.9% year-over-year. The AtriClip FLEX MINI and AtriClip PRO MINI were credited as key drivers due to the low profile of the “mini” devices. The company exited 2025 with more than 300 active accounts purchasing FLEX MINI, which contributed 18% of worldwide left atrial appendage management revenue in 2025. In open AFib ablation, revenue grew 17%, primarily driven by the Encompass clamp. Encompass was present in more than 830 accounts worldwide, and U.S. open ablation sales were $143.8 million, up 16.3% year over year, with Encompass contributing more than 60% of U.S. open ablation revenue in 2025. The company also noted it has several clinical trials in the pipeline, on top of new product developments for 2026. Its ongoing LEAPS trial, which currently has 6,573 patients enrolled, is aimed at expanding treatment in cardiac surgery patients without pre-existing AFib. Its 960 patient BOX X NoAF trial is evaluating ablation intended to reduce postoperative AFib in cardiac surgery patients without pre-existing AFib. ArtiCure is also working on a dual-energy EnCompass clamp intended to shorten RF ablation times and add PFA as a complementary energy source. Boston Scientific Boston Scientific saw a profit boom in the third quarter of 2025, making the lion's share of its revenue in Q3 through the heart device market, benefitting from pacemaker and stent sales. The company's cardiovascular unit posted quarterly sales of $3.34 billion, beating estimates of $3.27 billion. Its cardiovascular segment saw 22.4% net sales growth. In April, Boston Scientific’s Farapulse pulsed field ablation system triumphed over the PFA systems of major competitors, including Medtronic, as the company has continued to assert its dominance in the cardiovascular space. In July, the company secured label expansion from FDA for its Watchman FLX and Watchman FLX Pro. Boston Scientific estimates that expanding the Watchman label to post-ablation patients would expand its patient population by 1 to 2 million globally. Medtronic Medtronic’s financial results for the second quarter of 2026, ending October 24, 2025, demonstrated a revenue increase of 6.6%. The successful quarter was led by its cardiovascular and diabetes segments, which have continued to triumph over competitors despite the overcrowded markets. Medtronic’s cardiovascular portfolio revenue reached $3.436 billion, an increase of 10.8%, led by its cardiac rhythm & heart failure, structural heart & aortic, and coronary & peripheral vascular brands. Medtronic’s PFA portfolio also led the company’s cardiac ablation solutions revenue to grow 71% worldwide, and 128% in the U.S. The quarter saw Medtronic’s strongest cardiovascular revenue growth in over a decade. Q3 was just as successful for the company. Medtronic achieved 8.7% revenue growth during its third quarter of fiscal year 2026, reaching $9 billion to achieve its highest revenue growth in 10 quarters. The company’s PFA portfolio led a 137% growth in the U.S. specifically, while its Cardiac Ablation Solutions segment grew by 80%. The company also expanded its presence in the cath lab market, exercising its option to acquire CathWorks in a deal valued at up to $583 million. In January, it saw major clearance milestones for PFA, and the same month it invested $90M in Anteris Technologies for DurAVR TAVR device development. “Our PFA trajectory is strong, and we're progressing on multiple billion-dollar opportunities. We're reinforcing our future pipeline, and we're committed to organic and inorganic investment to further bolster the portfolio. Bottom line, we are delivering,” Geoff Martha, Medtronic chairman and CEO, said in a prepared statement.

并购上市批准

100 项与 AtriCure, Inc. 相关的药物交易

登录后查看更多信息

100 项与 AtriCure, Inc. 相关的转化医学

登录后查看更多信息