Stereotaxis, a US-based provider of surgical robotics for minimally invasive endovascular intervention, has received European CE mark approval for its MAGiC ablation catheter.
MAGiC is a robotically navigated magnetic ablation catheter designed to perform cardiac ablation procedures that treat heart arrhythmia.
It was developed based on insights from more than 150,000 robotic ablation procedures performed over the course of nearly 20 years, using predecessor catheters.
Also, the catheter is designed to improve treatment precision and control during cardiac ablation while maintaining the safety advantage of a soft flexible catheter, said Stereotaxis.
Stereotaxis chairman and CEO David Fischel said: “We are thrilled to announce this significant milestone and introduce the MAGiC catheter to European physicians and patients.
“We want to thank and recognise the significant contributions from clinicians who guided us throughout the development efforts and team members of Stereotaxis and Osypka that made this possible.
“We look forward to seeing MAGiC serve as one of the key pillars in our effort to make robotics broadly impactful and beneficial in electrophysiology and endovascular surgery.”
Stereotaxis said its MAGiC catheter builds on existing benefits of robotic cardiac ablation with design enhancements, including optimised navigation, force and stability.
The unique placement of magnets and design of the distal section of the catheter support intuitive navigation, consistent contact forces, and enhanced stability.
The catheter features iConnect and the eContact modules, which provide catheter tissue contact information, along with clear electrogram and responsive temperature data.
Also, it comes with a low-flow uniform cooling feature, where its tip is cooled with low-flow irrigation that reduces the overall fluid load while protecting against char and coagulation.
The MAGiC catheter has been approved in Europe with a label that indicates the delivery of local lesions in cardiac tissue for the treatment of cardiac arrhythmias.
Obtaining the CE Mark follows years of effort and substantial investments in catheter development, testing, manufacturing, and preclinical and clinical research. Furthermore, MAGiC showed a positive clinical experience, with wide adoption of MAGiC across robotic users in an ongoing clinical study in Europe, according to Stereotaxis.
