Stereotaxis (NYSE:STXS) has announced that it has submitted its robotically navigated catheter, EMAGIN 5F, for FDA regulatory clearance.
According to Sterotaxis, EMAGIN 5F, short for endovascular magnetic intervention, is a catheter guide designed to expand usage or robotic magnetic navigation into the broader endovascular field.
“Robotic magnetic navigation offers significant promise to address clinical challenges we face in the neurointerventional field by enabling safe and rapid navigation through tortuous vasculature,” remarked Professor Timo Krings, chair of the Division of Neurointerventional Radiology at Beth Israel Lahey Health in Boston and professor of radiology at UMass TH Chan School of Medicine.
“I’m excited by the opportunity to help pioneer this technology, evaluate and demonstrate its clinical value, and explore entirely new applications that may become possible. Our field is uniquely poised to benefit from robotics and we look forward to advancing the technology and clinical science over the coming years,” he added.
Dr. Kalpa De Silva, interventional cardiologist at St. Thomas’ Hospital, Guy’s and St. Thomas’ NIH Foundation Trust in London, commented, “I see significant promise in the use of the robotically-steered EMAGIN catheter to enhance the safety, precision, and efficacy of various challenging procedures including renal denervation and complex percutaneous coronary interventions. I look forward to helping pioneer this technology.”
