Varian Receives Investigational Device Exemption for Cardiac Radioablation Clinical Trial
Trial will compare patients that undergo cardiac radioablation with Varian's CRA system vs. standard-of-care catheter ablation.
Varian, a Siemens Healthineers company, announced FDA IDE approval for its pivotal RADIATE-VTTM clinical trial. The RADIATE-VT trial will be an international, multi-center, randomized controlled trial to evaluate the safety and efficacy of cardiac radioablation (CRA) compared to repeat catheter ablation for patients with high-risk refractory ventricular tachycardia (VT).
Varian's CRA system received FDA Breakthrough Device designation in 2021, and is designed to provide non-invasive delivery of precisely targeted high-dose radiation, enabling ablation across the full thickness of the myocardium, which may offer the potential to improve control of the patient's VT compared to the current standard of care.
Read more about the clinical trial.
FDA issues de novo clearance for SonoMotion’s Stone Clear device, for kidney stone treatment
Stone Clear is the first and only device cleared by the FDA that uses external ultrasound pulses to facilitate passage of post-lithotripsy kidney stone fragments without surgery.
