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Steotaxis announces regulatory filing for MAGiC ablation catheter in Europe and US

thedailyposting.comBy thedailyposting.comMarch 4, 2024No Comments

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Stereo Taxi Co., Ltd.

Stereo Taxi Co., Ltd.

ST. LOUIS, March 4, 2024 (GLOBE NEWSWIRE) — Stereotactic Taxi (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular interventions, announced today that MAGiC™ catheters have recently been introduced in both countries of the United States. These filings follow successful initial clinical results from ongoing clinical trials.

Stereotaxis’ MAGiC catheter is a robotically operated magnetic ablation catheter designed to perform minimally invasive cardiac ablation procedures. Based on experience gained through nearly 20 years and more than 100,000 procedures using existing robotic-guided ablation catheters, MAGiC is designed to improve patient safety, procedure effectiveness and efficiency, and physician experience. It incorporates a variety of features.

The first human surgery using the MAGiC catheter began earlier this year as part of a prospective, multicenter clinical study. Excellent initial results in his first 20 procedures were submitted for publication in a major electrophysiology journal, and the authors documented his 100% acute efficacy and absence of adverse events. These results were included in a regulatory filing.

The MAGiC catheter’s CE mark and PMA supplemental filings reflect the culmination of extensive design, development, manufacturing, and testing efforts. This catheter is the first in a series of interventional devices being developed by Stereotaxis and will serve as a platform for future innovations. Stereotaxis anticipates that upon regulatory approval, the MAGiC catheter will be commercially available to the robotic electrophysiologist community.

“We are pleased to reach this important milestone for Stereotaxis and the physician community that is pioneering the forefront of robotics in electrophysiology,” said Stereotaxis Chairman and CEO ) says David Fishel. “We look forward to working collaboratively with regulators as they review our application and hope to make the benefits of MAGiC available to patients and physicians in the near future.”

About stereotaxic fixation
Stereotactic Taxi (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular interventions. Its mission is to discover, develop, and deliver robotic systems, equipment, and information solutions for interventional laboratories. These innovations help physicians deliver unparalleled patient care with robotic precision and safety, expand access to minimally invasive treatments, and enhance productivity, connectivity, and intelligence in the operating room. . Stereotactic techniques have been used by him to treat over 100,000 patients in the United States, Europe, Asia and elsewhere. For more information, please visit www.Stereotaxis.com.

This press release contains statements that may constitute “forward-looking” statements and generally include statements such as “believe,” “estimate,” “anticipate,” “expect,” or similar expressions. Contains expressions. Actual results may differ materially and factors that could cause or contribute to such difference include our ability to manage our expenses at sustainable levels, market acceptance of our products, and the global economy. Examples include, but are not limited to, the impact of the current situation on the company. the ability and willingness of our customers to purchase our technology, competitive factors, changes resulting from healthcare policy, dependence on third-party vendors, the timing of regulatory approvals, the impact of pandemics or other disasters, our periodic reports and other Other risks described in this report 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. . Because some of these purchase orders and other commitments are subject to unforeseen circumstances beyond our control and may be amended, modified, delayed, or canceled, There is no guarantee that we will recognize any related revenue. .

Company contact information:
David L. Fischel
Chairman and CEO

Kimberly R. Peary
CFO

314-678-6100
Investors@Stereotaxis.com

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