First Clinical Results from MAGiC Catheter Study Published in the Journal of Interventional Cardiac Electrophysiology

Rhea-AI Summary

Stereotaxis (NYSE: STXS), a pioneer in surgical robotics, announced the publication of first clinical results for its MAGiC catheter in the Journal of Interventional Cardiac Electrophysiology. The prospective multi-center study demonstrated an impressive 94% acute efficacy rate in treating various heart arrhythmias.

The study, conducted at Copenhagen University Hospital Rigshospitalet and Vilnius University Hospital Santaros Klinikos, included 67 patients with various arrhythmias. The average procedure time was 83 minutes skin-to-skin, with a low procedure-related adverse event rate of 1.5%. Patient enrollment continues with approximately 100 patients enrolled to date, with efficacy assessments ongoing for up to one year.

The MAGiC catheter, designed for robotically-navigated magnetic ablation procedures, showed notable improvements in stability, eliminating the need for sheaths for catheter support. The technology has already been utilized in treating over 150,000 patients across leading hospitals globally.

Positive

• Strong 94% acute efficacy rate in clinical trials
• Low 1.5% procedure-related adverse event rate
• Improved catheter stability reported by experienced physicians
• Lower irrigation rates beneficial for patients with poor cardiac and renal function
• Successful treatment across broad spectrum of arrhythmias in all four heart chambers
• Technology already implemented in over 100 leading hospitals globally

Negative

• Study limited to initial analysis of 67 patients
• Long-term efficacy data still pending for up to one year
• Adverse events noted in high-risk patients, though within expected range

ST. LOUIS, July 01, 2025 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced the publication of initial clinical results using the MAGiC catheter in the Journal of Interventional Cardiac Electrophysiology. Titled “First In‑Human Results of the MAGiC Robotic Magnetic Navigation Radiofrequency Ablation Catheter,” the publication is the first peer-reviewed literature supporting the efficacy and safety of Stereotaxis’ MAGiC catheter.

“We are delighted to see the strong efficacy and safety profile of MAGiC published in a prestigious journal,” said David Fischel, Stereotaxis Chairman and CEO. “This publication supports our ongoing launch of MAGiC across Europe. We appreciate the pioneering electrophysiologists at Copenhagen University Hospital Rigshospitalet and Vilnius University Hospital Santaros Klinikos who made this possible.”

The prospective multi-center, single-arm study used MAGiC to treat patients with a broad spectrum of arrhythmia – atrioventricular nodal reentrant tachycardia, Wolf-Parkinson-White syndrome, atrial fibrillation, atrial flutter, premature ventricular contractions, and ventricular tachycardia – in all four chambers of the heart. The initial analysis of the study includes acute efficacy and safety for 67 patients. Patient enrollment is ongoing with approximately a hundred patients enrolled to date and continued assessments of sustained efficacy ongoing for up to one year.

Acute efficacy of MAGiC in this study was 94%. The study authors detail how this compares favorably to acute efficacy results published in larger ablation registries using other catheters. Procedure time averaged 83 minutes skin-to-skin. A procedure-related adverse event rate of 1.5% reflected known risks of RF ablation in high-risk patients and was not caused by any catheter related malfunction. The study authors concluded that the study demonstrated “good acute efficacy and safety of the MAGiC RMN ablation catheter independent of underlying arrhythmias.”

The authors of the study, with combined experience treating over 6,500 robotic procedures with previously available magnetic catheters, noted the noticeably improved stability of MAGiC, not needing to use sheaths for catheter support and stability, steady catheter tip temperatures during ablation, low irrigation rates benefiting patients with poor cardiac and renal function, and the potential for more efficient and effective lesions.

Stereotaxis’ MAGiC catheter is a robotically-navigated magnetic ablation catheter designed to perform cardiac ablation procedures that treat heart arrhythmia. The MAGiC catheter is designed to enhance treatment precision and control during cardiac ablation, while maintaining the intrinsic safety advantage of a soft flexible catheter. Stereotaxis’ robotic technologies are at the forefront of efforts to advance robotics in minimally-invasive endovascular surgeries. Its robots have already been used by physicians at over 100 leading hospitals globally to treat over 150,000 patients.

The publication can be found at https://link.springer.com/article/10.1007/s10840-025-02082-z. To access a complete database of more than 500 scientific publications referencing Stereotaxis technology, visit www.RoboticEP.com/clinical-data/publications-database/.

About Stereotaxis
Stereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to treat over 150,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit www.stereotaxis.com

This press release includes statements that may constitute "forward-looking" statements, usually containing the words "believe”, "estimate”, "project”, "expect" or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that would cause or contribute to such differences include, but are not limited to, the Company's ability to manage expenses at sustainable levels, acceptance of the Company's products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its technology, competitive factors, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, statements relating to our recent acquisition of APT, including any benefits expected from the acquisition, and other risks discussed in the Company's periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company's control and may be revised, modified, delayed, or canceled.

Stereotaxis Contacts:
David L. Fischel
Chairman and Chief Executive Officer

Kimberly Peery
Chief Financial Officer

314-678-6100
Investors@Stereotaxis.com

FAQ

What were the key results of Stereotaxis (STXS) MAGiC catheter clinical trial?

The trial showed a 94% acute efficacy rate with an average procedure time of 83 minutes and a low 1.5% adverse event rate across 67 patients treated for various heart arrhythmias.

How many patients have been treated with Stereotaxis (STXS) robotic technology?

Stereotaxis' robotic technologies have been used to treat over 150,000 patients at more than 100 leading hospitals globally.

What types of heart conditions can the MAGiC catheter treat?

The MAGiC catheter can treat a broad spectrum of arrhythmias including atrioventricular nodal reentrant tachycardia, Wolf-Parkinson-White syndrome, atrial fibrillation, atrial flutter, premature ventricular contractions, and ventricular tachycardia.

What are the main advantages of the Stereotaxis MAGiC catheter?

The key advantages include improved stability, no need for sheaths for catheter support, steady tip temperatures during ablation, and lower irrigation rates which benefit patients with poor cardiac and renal function.

Where is the Stereotaxis MAGiC catheter currently available?

The MAGiC catheter is currently being launched across Europe, with clinical trials conducted at Copenhagen University Hospital Rigshospitalet and Vilnius University Hospital Santaros Klinikos.