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International Journal of Cardiology Publishes Data Demonstrating Superior Outcomes of Stereotaxis Robotic Cardiac Ablation in Pediatric Patients

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On October 12, 2021, Stereotaxis (NYSE: STXS) announced a publication highlighting their robotic technology's effectiveness in treating cardiac arrhythmias in pediatric patients. The study, which included 223 patients and was conducted at Erasmus Medical Center, revealed that patients receiving Robotic Magnetic Navigation (RMN) had a 94.4% success rate in avoiding arrhythmia recurrence over a mean follow-up of 5.5 years. Notably, zero adverse events occurred with RMN, contrasting with 2.6% for manual methods, showcasing significant safety and efficacy benefits.

Positive
  • 94.4% success rate in preventing arrhythmia recurrence with RMN versus 85.5% for manual RF ablation and 59.0% for cryoablation.
  • Zero adverse events reported in RMN procedures, indicating significant safety.
  • Lowest radiation exposure associated with RMN, reducing risks for pediatric patients.
Negative
  • None.

ST. LOUIS, Oct. 12, 2021 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), the global leader in innovative robotic technologies for the treatment of cardiac arrhythmias, today announced a publication in the International Journal of Cardiology: Heart & Vascular demonstrating superior safety and efficacy of Stereotaxis’ robotic technology to treat atrioventricular reentry tachycardia (AVRT) and atrioventricular nodal reentry tachycardia (AVNRT) in pediatric patients with heart rhythm disease. The 223-patient study, conducted at Erasmus Medical Center in Rotterdam, the Netherlands, compared Robotic Magnetic Navigation (RMN) guided cardiac ablation to manual radiofrequency (RF) ablation and manual cryoablation.

“We are excited to share data from this large long-term comparative study,” said Dr. Anne-Marie Noten, author of the publication. “It builds upon the significant body of evidence supporting the clinical value of robotics for arrhythmia patients, particularly the most vulnerable patients with complex disease.”

The study’s primary endpoint was long-term freedom from arrhythmia recurrence, with a mean follow-up time of 5.5 years. AV(N)RTs cause abnormally fast heartbeats and are the most common supraventricular tachyarrhythmias (SVT) in children without structural heart disease. Left untreated, frequent episodes may weaken the heart and lead to heart failure. Median age of patients in the study was 14 years at the time of treatment. Patients treated using RMN had 94.4% freedom from arrhythmia recurrence through long-term follow-up, compared to only 85.5% and 59.0% in patients treated with manual RF ablation or cryoablation, respectively (p<0.01).

Although cardiac ablation is a common treatment for AV(N)RT, there is risk of procedural complications, and the impact of procedural radiation on pediatric patients is a concern. In this study, patients who received catheter ablation with RMN experienced zero adverse events, compared with a 2.6% rate of adverse events for manual RF ablation and 2.6% for cryoablation. X-ray exposure was lowest in the RMN procedures, with exposure being 34% and 38% higher with manual RF ablation and cryoablation procedures, respectively.

“Particularly in small hearts, the flexibility and versatility of a magnetic catheter with Stereotaxis allows us to perform cardiac ablation without being limited to fixed, pre-defined curves,” said Dr. Tamas Szili-Torok, cardiac electrophysiologist and associate professor at Erasmus Medical Center. “The stability and precision of robotics enables us to provide the best care for our patients. We are proud to advance the frontiers of patient care and the scientific knowledge in electrophysiology, particularly when we can improve the health of children we are entrusted to treat.”

The publication can be found at https://www.sciencedirect.com/science/article/pii/S235290672100169X. To access a complete database of more than 400 scientific publications referencing Stereotaxis technology, visit www.RoboticEP.com/clinical-data/publications-database/.

About Stereotaxis
Stereotaxis (NYSE: STXS) is the global leader in innovative robotic technologies designed to enhance the treatment of arrhythmias and perform endovascular procedures. 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, improved lab efficiency and productivity, and enhanced integration of procedural information. Stereotaxis’ Robotic Magnetic Navigation technology is used in the United States, Europe, Asia, and elsewhere. For more information, please visit www.Stereotaxis.com or follow us on Facebook, Twitter, LinkedIn, Instagram, and YouTube.

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, 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.

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

Kimberly Peery
Chief Financial Officer

314-678-6100
investors@stereotaxis.com


FAQ

What were the results of the Stereotaxis study on robotic cardiac ablation published on October 12, 2021?

The study found that the Robotic Magnetic Navigation technology achieved a 94.4% success rate in preventing arrhythmia recurrence, while manual RF ablation and cryoablation had lower rates of 85.5% and 59.0%, respectively.

How does Stereotaxis' robotic technology compare to manual methods in terms of safety?

The study reported zero adverse events with Stereotaxis' Robotic Magnetic Navigation, while manual RF and cryoablation procedures had an adverse event rate of 2.6%.

What is the significance of the publication in the International Journal of Cardiology for Stereotaxis (STXS)?

The publication reinforces the clinical value of Stereotaxis' technology in treating complex cardiac arrhythmias in children, contributing to its reputation as a leader in robotic solutions.

What age group was involved in the Stereotaxis cardiac ablation study?

The median age of patients in the study was 14 years at the time of treatment.

Where can I access the Stereotaxis study published in October 2021?

The publication is available in the International Journal of Cardiology: Heart & Vascular, and can be accessed online through ScienceDirect.

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