Petition Seeks to Restrict Da Vinci Off-Label Use

A citizen petition from Harmed Americans for Reform in Medical-Device Safety is asking FDA to restrict the off-label use of the Da Vinci Robotic System and video-assisted thoracoscopy (VATS) devices to perform the “hybrid convergent cardiac ablation” protocol in patients with isolated atrial fibrillation. It also urges the agency to request information from Intuitive Surgical (Da Vinci maker) and VATS device manufacturers, including Olympus, about any off-label promotion of their medical devices for the cardiac ablation protocol.

The petition says there is “absolutely no evidence to show that the Da Vinci hybrid convergent approach or VATS hybrid convergent approach to epicardial ablation are safer than the subxiphoid approach to the mediastinum. Indeed, the more invasive VATS and robotic hybrid convergent approaches have a significantly worse safety profile and are associated with major adverse events.”