The St. Louis–based robotic surgery company submitted Magic for both CE mark and FDA approval nearly a year ago; it still awaits an FDA nod in the U.S.
Magic performs cardiac ablation procedures to treat heart arrhythmia.
Stereotaxis says it designed the Magic catheter to enhance treatment precision and control during cardiac ablation while keeping the intrinsic safety advantage of a soft, flexible catheter. The design drew on nearly 20 years of insights from 150,000 robotic procedures using predecessor catheters.
According to the company, the Magic catheter’s design enhancements include:
- The unique placement of magnets and catheter distal section design support intuitive navigation, consistent contact forces, and enhanced stability.
- Magic is available with iConnect and the eContact module, which offer catheter tissue contact information and electrogram and responsive temperature data to support physician decisions.
- Cooling of the catheter tip is achieved with low-flow irrigation to substantially reduces the overall fluid load on patients while protecting against char and coagulation.
Stereotaxis described the Magic catheter’s European labeling as broad, including the delivery of “local lesions in cardiac tissue for the treatment of cardiac arrhythmias.” Clinical experience from an ongoing European clinical study should support broad adoption of Magic across robotic users, according to the company,
“We are thrilled to announce this significant milestone and introduce the Magic catheter to European physicians and patients,” Stereotaxis CEO David Fischel said in a news release. “We want to thank and recognize 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.”
