Stereotaxis today announced it submitted its EMAGIN 5F and MAGiC catheters for FDA clearance.
EMAGIN 5F, short for Endovascular Magnetic Intervention, is a 5-French diameter that navigates tortuous venous and arterial vasculature. Stereotaxis designed it to enable efficient and safe navigation to access difficult-to-reach vascular anatomy.
The company said EMAGIN 5F expands the established benefits of its Robotic Magnetic Navigation into multiple new clinical applications, including minimally invasive for stroke, cancer and cardiovascular disease.
“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,” said Timo Krings, chair of the division of neurointerventional radiology at Beth Israel Lahey Health in Boston. “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.”
In addition to the FDA 510(k) submission, Stereotaxis expects to submit the catheter for CE mark clearance in Europe this month. It expects to launch EMAGIN 5F in the second half of 2025 following regulatory clearances.
The MAGiC Sweep catheter is a high-density EP mapping catheter the company designed for use with Stereotaxis’ Robotic Magnetic Navigation systems.
“The development of the first ever robotically navigated high-density mapping catheter is a major milestone for the EP field,” said Dr. Roderick Tung, chief of cardiology and director of cardiovascular clinical research at the University of Arizona College of Medicine. “Mapping with multi-electrode catheters has taught us so much in both mechanism and therapy for both atrial and ventricular arrhythmias. Remaining limited to only point-by-point mapping has held back the adoption of robotic navigation, as we have become accustomed to seeing human arrhythmias in exquisitely high resolution. We look forward to the positive impact we expect MAGiC Sweep to have on our patients and new possibilities in the field.”
The company expects to submit MAGiC Sweep for CE mark clearance in Europe later in March. It expects to initiate a broad commercial launch in the second half of 2025 following regulatory clearances.
