Varian announced today that it received FDA breakthrough device designation for its cardiac radioablation (CRA) system.
Palo Alto, Calif.-based Varian, a recently acquired Siemens Healthineers company, develops the CRA system as a noninvasive therapy for select patients with refractory ventricular tachycardia (VT), according to a news release.
VT, a fast, abnormal heart rate that could lead to sudden cardiac arrest, can be treated with an implantable cardioverter-defibrillator (ICD), antiarrhythmic medications or an invasive catheter ablation procedure. Still, Varian says those methods are often insufficient in controlling VT.
The Varian CRA system won the breakthrough nod because it could offer a more effective treatment for refractory VT through the noninvasive targeting and delivery of ablative energy across the full thickness of the myocardium, unlike conventional catheter ablation.
Varian believes that if the planned clinical studies support its CRA approach, it could be possible to achieve better and safer outcomes requiring less time than current surgical modalities.
“Early positive clinical results suggest that non-invasive cardiac radioablation could offer new hope for patients with refractory VT,” Varian president of proton solutions & growth office Kolleen Kennedy said in the release. “We look forward to developing this important new technology and working closely with the FDA to develop the appropriate clinical program for market approval.”