Stereotaxis Announces First MAGiC Procedures in the United States
Rhea-AI Summary
Stereotaxis (NYSE: STXS) announced the first United States patients treated with MAGiC™, its robotically-navigated magnetic ablation catheter, following FDA PMA approval on April 22, 2026. The initial U.S. case, performed by Dr. Nathan McConkey, treated complex congenital heart disease via basilic vein access with no recurrence in the weeks after the procedure. MAGiC is indicated for mapping, pacing, and creating endocardial lesions to treat supraventricular tachycardias in congenital heart disease patients with limited conventional access.
The release highlights improved catheter stability, contact force, and energy delivery and positions MAGiC to expand minimally invasive ablation options for challenging anatomy.
Positive
- FDA PMA approval for MAGiC catheter
- First successful U.S. MAGiC procedures completed
- Indication: specifically approved for congenital heart disease patients with limited manual access
Negative
- Clinical follow-up reported only for a matter of weeks post-procedure
- Indication scope limited to congenital heart disease patients with restricted vascular or chamber access
News Market Reaction – STXS
In the Apr 22 session, STXS gained 1.04%, reflecting a mild positive market reaction. Argus tracked a trough of -2.6% from its starting point during tracking. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Apr 15 | Robocath acquisition | Positive | -1.0% | Definitive agreement to acquire Robocath with upfront and milestone payments. |
| Apr 06 | Product clearance | Positive | +0.5% | FDA 510(k) clearance and launch of the Synchrony interventional lab display. |
| Mar 09 | Earnings results | Positive | -4.8% | 2025 revenue growth, strong recurring revenue, and guidance above $40M for 2026. |
| Feb 12 | Earnings date set | Neutral | -0.5% | Announcement of date and logistics for 2025 results and conference call. |
| Feb 09 | New EP program | Positive | +4.4% | Klinikum Fürth establishes a Genesis robotic arrhythmia program in Germany. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent positive fundamental and product news has often met with muted or negative next-day moves, while select commercial adoption updates have aligned with gains.
Over the last few months, Stereotaxis reported strong 2025 growth, with guidance targeting revenue above $40M in 2026, and secured broad approvals for GenesisX and MAGiC. It launched the Synchrony display system and announced a definitive agreement to acquire Robocath on Apr 15, 2026. A German hospital also established a Genesis robotic arrhythmia program. Today’s first U.S. MAGiC procedures build directly on prior MAGiC approvals and commercialization milestones described in recent filings and releases.
Key Terms
pma approval regulatory
ablation catheter medical
cardiac ablation medical
arrhythmia medical
cardioversion medical
cavotricuspid isthmus medical
basilic vein medical
supraventricular tachycardia medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
ST. LOUIS, April 22, 2026 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced the first patients in the US have been successfully treated using MAGiC™.
MAGiC, Stereotaxis’ proprietary robotically-navigated magnetic interventional cardiac ablation catheter, recently received Food & Drug Administration PMA approval. It is the first ablation catheter specifically approved to treat arrhythmia in patients with complex congenital heart disease. Dr. Nathan McConkey, Cardiac Electrophysiologist at Oregon Health & Science University, performed the first MAGiC procedure in the United States on a patient with complex congenital heart disease who was experiencing extremely frequent episodes of atrial flutter, requiring cardioversion or pace termination on a near weekly basis. Previous attempts at ablation using manual catheters were unsuccessful due to the patient’s challenging anatomy. By approaching the cavotricuspid isthmus from above via access from the basilic vein in the arm, Dr. McConkey was able to successfully ablate the target tissue and treat the patient, who has not experienced a recurrence in the weeks following the procedure.
“MAGiC is an outstanding tool for reaching challenging substrate in patients with complicated anatomy,” said Dr. McConkey. “The stability, contact force, and energy delivery are all a substantial improvement over older magnetic catheters, and many ablations in my complex congenital patients would be impossible without this new technology.”
“As one of the earliest adopters of Robotic Magnetic Navigation, I’ve seen the technology advance significantly in recent years and evolve into a core part of our practice,” said Dr. Gery Tomassoni, Director of Electrophysiology at Baptist Health Lexington. “We now rely on it routinely to treat a high volume of complex arrhythmia patients with greater precision and safety. The MAGiC catheter is a meaningful, long-awaited advancement that will further enhance our ability to improve patient care.”
Stereotaxis’ MAGiC catheter is a robotically-navigated magnetic ablation catheter designed to perform cardiac ablation procedures that treat heart arrhythmia. The catheter is designed to expand access to minimally-invasive cardiac ablation therapy and enhance outcomes in complex underserved patient populations. The catheter is navigated with a compatible Robotic Magnetic Navigation system, a novel technology using highly-precise computer-controlled magnetic fields to offer unprecedented levels of catheter maneuverability, precision, and, stability.
The MAGiC Magnetic Interventional Ablation Catheter is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, and for the creation of endocardial lesions to treat supraventricular tachycardia (e.g., macroreentrant atrial tachycardia, focal atrial tachycardia, atrioventricular nodal reentrant tachycardia, and atrioventricular reentrant tachycardia) in patients with congenital heart disease in whom vascular or target chamber access by conventional manual catheter navigation is limited due to underlying anatomic abnormalities and/or previous surgical interventions.
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 within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934, including statements regarding the completion of the Company’s offering and the anticipated use of proceeds therefrom, 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, and other risks discussed in the Company's periodic and other filings with the SEC. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this press release. There can be no assurance that the Company will recognize revenue related to customer 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
