This device just got cleared by the FDA. What your planning team needs before it shows up on the equipment list.
Device: Synergy Ablation System
Decision Date: 2026-05-06
Applicant: AtriCure, Inc.
Medical Specialty: Cardiovascular
Pathway: PMA
About: A surgical cardiac ablation device for treating persistent atrial fibrillation during open concomitant CABG and or valve surgery.
Facility Planning Implications
- AtriCure requires ASU/ASB or MAG generator availability.
- Cardiac ORs need this ablation clamp in open-heart case carts.
- Supply teams must stock both 53 mm and 65 mm clamps.
- Concomitant AF workflows add setup steps within CABG and valve cases.
Compatibility and Integrations
Synergy Ablation System is compatible with ASU/ASB and MAG.
FAQ
What is Synergy Ablation System?
Synergy Ablation System is a surgical cardiac ablation device that uses bipolar radiofrequency energy to ablate cardiac tissue. It is intended to treat persistent and longstanding persistent atrial fibrillation.
What clinical setting is Synergy Ablation System used in?
It is used in the cardiac operating room during open concomitant coronary artery bypass grafting and or valve replacement or repair. The target users are cardiac surgical teams treating AF during open-heart procedures.
What room or space requirements does Synergy Ablation System need?
The clamp itself does not drive room construction, but it does require compatible ablation generator support in the OR. Facilities teams should plan storage, sterile supply access, and generator availability in cardiac surgery rooms.
What systems does Synergy Ablation System need to integrate with?
The device must work with AtriCure generator platforms listed as ASU/ASB and MAG. Planning teams should verify generator compatibility, accessory standardization, and case cart workflow.
Sources & image credit: FDA PMA Database · AtriCure
AI summary based on official and manufacturer data.