AtriCure, Inc. engages in the development, manufacture, and sale of surgical ablation of cardiac tissue, and systems for the exclusion of the left atrial appendage. Its products include radio frequency (RF) ablation pacing and sensing, cryo, left atrial appendage management, soft tissue dissection, estech surgical instrumentation, and cart configuration. It operates through the following geographical segments: United States, Europe, Asia, and Other International. The company was founded in 1994 and is headquartered in Mason, OH.
Clinical Trials
35
5 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2000
Active, not recruiting
4
11.4%
Completed
19
54.3%
Not yet recruiting
1
2.9%
Recruiting
5
14.3%
Suspended
1
2.9%
Unknown
2
5.7%
Withdrawn
3
8.6%
No approval data available
- AtriCure has enrolled the first patient in the BoxX-NoAF clinical trial, evaluating combined surgical ablation and left atrial appendage exclusion to prevent new-onset atrial fibrillation after cardiac surgery. - Post-operative atrial fibrillation affects up to 50% of cardiac surgery patients and is associated with increased mortality, stroke risk, and hospital costs. - The randomized controlled trial will enroll up to 960 subjects at 75 sites worldwide and represents the first study designed to demonstrate superiority of this combined approach over no treatment. - If successful, the trial could position AtriCure's EnCompass clamp and AtriClip systems as the only FDA-approved devices for preventing post-operative atrial fibrillation.
- AtriCure has completed enrollment of 6,500 patients across 137 global centers in the LeAAPS clinical trial, marking the largest cardiac surgery device trial ever conducted. - The prospective, randomized, blinded superiority trial evaluates the AtriClip LAA Exclusion System for preventing ischemic stroke in cardiac surgery patients without prior atrial fibrillation history. - The trial targets a large underserved population of over one million annual cardiac surgery patients, with more than 70% having no preoperative atrial fibrillation diagnosis. - Results are expected to inform clinical practice guidelines and support expanded stroke prevention indications for AtriClip devices, with five years of follow-up planned.
• AtriCure's EPi-Sense system has gained FDA approval for treating long-standing persistent atrial fibrillation (Afib), offering a new option for a challenging patient population. • The Converge clinical trial demonstrated the superiority of Hybrid AF therapy using the EPi-Sense system compared to endocardial catheter ablation alone. • Hybrid AF therapy showed a 29% absolute improvement in efficacy at 12 months and a 35% absolute improvement at 18 months compared to catheter ablation. • The EPi-Sense system improves electrophysiology lab efficiency by reducing endocardial ablation times by over 40 minutes, enhancing patient throughput.
