Home » Varian’s Cardiac Radioablation System Earns FDA Breakthrough Device Status
Varian’s Cardiac Radioablation System Earns FDA Breakthrough Device Status
Devices Submissions and Approvals
Varian has received Breakthrough Device designation from the FDA for its cardiac radioablation (CRA) system.
The Siemens Healthineers subsidiary is developing the device as a noninvasive therapy for patients who experience refractory ventricular tachycardia, also known as electrical storm.
Varian’s CRA system differs from conventional catheter ablation because it enables noninvasive targeting and delivery of ablative energy across the heart’s entire muscular tissue.