ST. LOUIS, March 03, 2025 (GLOBE NEWSWIRE) — Stereotaxis STXS, a pioneer and international chief in surgical robotics for minimally invasive endovascular intervention, at present introduced FDA regulatory submission for the MAGiC Sweep™ catheter. MAGiC Sweep is the primary high-density EP mapping catheter developed to be robotically navigated utilizing Stereotaxis’ Robotic Magnetic Navigation techniques.
Excessive density mapping has reworked the EP discipline, enhancing cardiac ablation procedures by enabling extra environment friendly, detailed and exact identification of arrhythmia origin. The mixture of high-density mapping with robotics is designed to supply a number of enhancements over what has been out there: extremely fast and detailed electroanatomical mapping collected concurrently from 20 electrodes, mapping with the inherent security of an atraumatic catheter, the flexibility to map in any other case tough to achieve areas of the center, improved robotic procedural workflow, and extra anatomically correct maps by avoiding the distension attributable to inflexible catheters. Stereotaxis’ robotic know-how permits for automated mapping that will likely be enhanced together with MAGiC Sweep.
“The event of the primary ever robotically navigated high-density mapping catheter is a serious milestone for the EP discipline,” stated Dr. Roderick Tung, Chief of Cardiology and Director of Cardiovascular Scientific Analysis at The College of Arizona School of Drugs – Phoenix. “Mapping with multi-electrode catheters has taught us a lot in each mechanism and remedy for each atrial and ventricular arrhythmias. Remaining restricted to solely point-by-point mapping has held again the adoption of robotic navigation, as we now have grow to be accustomed to seeing human arrhythmias in exquisitely excessive decision. We look ahead to the optimistic influence we count on MAGiC Sweep to have on our sufferers and new prospects within the discipline.”
Stereotaxis submitted a 510(ok) utility for MAGiC Sweep with the FDA and expects to submit MAGiC Sweep for European CE Mark clearance this month. MAGiC Sweep was designed and is manufactured by Stereotaxis’ fully-owned subsidiary Entry Level Applied sciences in Minnesota. Stereotaxis expects to provoke a broad business launch of MAGiC Sweep following anticipated approvals within the second half of this 12 months. That is the primary devoted diagnostic catheter made out there for Stereotaxis’ robotic know-how, complementing robotic ablation catheter improvements.
“Stereotaxis is quickly evolving in direction of changing into a robotic chief with a broad portfolio of proprietary differentiated catheters,” stated David Fischel, Stereotaxis Chairman and CEO. “The acquisition of Entry Level Applied sciences mirrored our dedication to this technique and has accelerated our progress. The submissions of MAGiC Sweep – together with our first vascular steering catheter EMAGIN 5F, introduced in a separate press launch this morning – mirror the primary tangible milestones on this strategic transformation.”
About Stereotaxis
Stereotaxis STXS is a pioneer and international chief in progressive surgical robotics for minimally invasive endovascular intervention. Its mission is the invention, growth and supply of robotic techniques, devices, and data options for the interventional laboratory. These improvements assist physicians present unsurpassed affected person care with robotic precision and security, develop entry to minimally invasive remedy, and improve the productiveness, connectivity, and intelligence within the working room. Stereotaxis know-how has been used to deal with over 150,000 sufferers throughout the USA, Europe, Asia, and elsewhere. For extra data, please go to www.stereotaxis.com
This press launch consists of statements that will represent “forward-looking” statements, normally containing the phrases “imagine”, “estimate”, “venture”, “count on” or related expressions. Ahead-looking statements inherently contain dangers and uncertainties that might trigger precise outcomes to vary materially. Elements that might trigger or contribute to such variations embody, however will not be restricted to, the Firm’s means to handle bills at sustainable ranges, acceptance of the Firm’s merchandise within the market, the impact of worldwide financial circumstances on the flexibility and willingness of consumers to buy its know-how, aggressive elements, adjustments ensuing from healthcare coverage, dependence upon third-party distributors, timing of regulatory approvals, the influence of pandemics or different disasters, statements regarding our latest acquisition of APT, together with any advantages anticipated from the acquisition, and different dangers mentioned within the Firm’s periodic and different filings with the Securities and Alternate Fee. By making these forward-looking statements, the Firm undertakes no obligation to replace these statements for revisions or adjustments after the date of this launch. There will be no assurance that the Firm will acknowledge income associated to its buy orders and different commitments as a result of a few of these buy orders and different commitments are topic to contingencies which can be outdoors of the Firm’s management and could also be revised, modified, delayed, or canceled.
Stereotaxis Contacts:
David L. Fischel
Chairman and Chief Govt Officer
Kimberly Peery
Chief Monetary Officer
314-678-6100
[email protected]
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