Sam Brusco, Associate Editor05.28.21
Varian (recently acquired by Siemens Healthineers), was granted FDA Breakthrough Device Designation for its cardiac radioabltion (CRA) system. Currently in development, the device aims to treat select patients with refactory ventricular tachycardia (VT), a fast, abnormal heart rate.
VT patients typically receive and implantable cardioverter-defibrillator (ICD), antiarrhythmic drugs, or catheter ablation. These can be insufficient to control the disease.
Instead of conventional catheter ablations, the Varian CRA system will enable nonivasive ablative energy targeting and delivery across the myocarduim's full thickness. This approach could lead to better outcomes, and prove safer and require less time than current procedures.
FDA's Breathrough Device program expedites the traditional review and assessment process to accelerate time-to-market for breakthrough therapies.
"Early positive clinical results suggest that non-invasive cardiac radioablation could offer new hope for patients with refractory VT," said Kolleen Kennedy, Varian’s president of Proton Solutions and Growth Office. "We look forward to developing this important new technology and working closely with the FDA to develop the appropriate clinical program for market approval."
VT patients typically receive and implantable cardioverter-defibrillator (ICD), antiarrhythmic drugs, or catheter ablation. These can be insufficient to control the disease.
Instead of conventional catheter ablations, the Varian CRA system will enable nonivasive ablative energy targeting and delivery across the myocarduim's full thickness. This approach could lead to better outcomes, and prove safer and require less time than current procedures.
FDA's Breathrough Device program expedites the traditional review and assessment process to accelerate time-to-market for breakthrough therapies.
"Early positive clinical results suggest that non-invasive cardiac radioablation could offer new hope for patients with refractory VT," said Kolleen Kennedy, Varian’s president of Proton Solutions and Growth Office. "We look forward to developing this important new technology and working closely with the FDA to develop the appropriate clinical program for market approval."
