Stereotaxis announces peer-reviewed results demonstrating the safety and efficacy of its MAGiC catheter for cardiac ablation procedures.
Quiver AI Summary
Stereotaxis has announced the publication of initial clinical results for its MAGiC catheter in the Journal of Interventional Cardiac Electrophysiology, marking the first peer-reviewed support for its efficacy and safety. The study, involving 67 patients with various arrhythmias, reported an acute efficacy of 94% and a low complication rate of 1.5%, demonstrating the catheter's strong performance in treating heart conditions. The MAGiC catheter aims to enhance precision and control during cardiac ablation procedures while retaining the advantages of a soft, flexible design. Stereotaxis’s robotic technologies have been widely adopted, having treated over 150,000 patients globally. The findings bolster the company’s ongoing launch efforts across Europe, backed by experiences from leading hospitals in Denmark and Lithuania.
Potential Positives
- Publication of initial clinical results for the MAGiC catheter in a prestigious journal, supporting the efficacy and safety of the product.
- Achieved a high acute efficacy rate of 94% in a multi-center study involving diverse arrhythmia treatments.
- Demonstrated a low procedure-related adverse event rate of 1.5%, reflecting the safety of the MAGiC catheter for high-risk patients.
- The ongoing launch of MAGiC across Europe is bolstered by this peer-reviewed evidence, enhancing market confidence and potential adoption.
Potential Negatives
- The press release does not provide comprehensive data regarding the long-term efficacy of the MAGiC catheter, limiting the information available about its overall performance over extended periods.
- The announcement highlights a procedure-related adverse event rate of 1.5%, which could raise concerns among potential customers and healthcare professionals regarding the safety of the device.
- Ongoing patient enrollment suggests that the study results are preliminary, indicating that Stereotaxis has not yet completed full validation of the MAGiC catheter's performance.
FAQ
What are the initial clinical results of the MAGiC catheter?
The MAGiC catheter demonstrated a 94% acute efficacy rate and a 1.5% procedure-related adverse event rate in initial clinical results.
Where can I find the published study on the MAGiC catheter?
The study titled “First In-Human Results of the MAGiC Robotic Magnetic Navigation Radiofrequency Ablation Catheter” is published in the Journal of Interventional Cardiac Electrophysiology.
What is the primary application of the MAGiC catheter?
The MAGiC catheter is designed for cardiac ablation procedures to treat various heart arrhythmias.
How does the MAGiC catheter improve treatment safety?
The MAGiC catheter features enhanced stability, does not require sheaths for support, and maintains safe catheter tip temperatures during ablation.
What innovations does Stereotaxis focus on?
Stereotaxis specializes in robotic systems and instruments for minimally invasive endovascular interventions, enhancing precision, safety, and patient care.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
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
[email protected]