Stereotaxis Announces Regulatory Submissions of the MAGiC Ablation Catheter in Europe and the United States
04 Março 2024 - 6:06PM
Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical
robotics for minimally invasive endovascular intervention, today
announced that regulatory submissions were made recently in both
Europe and the United States for the MAGiC™ catheter. These
submissions follow successful initial clinical results in an
ongoing trial.
Stereotaxis’ MAGiC catheter is a robotically
navigated magnetic ablation catheter designed to perform minimally
invasive cardiac ablation procedures. Building on the experience
gained through over 100,000 procedures during the course of nearly
twenty years with existing robotically navigated ablation
catheters, MAGiC incorporates various features that are designed to
enhance patient safety, procedural effectiveness and efficiency,
and the physician experience.
The first human procedures with the MAGiC
catheter commenced earlier this year as part of a prospective
multi-center clinical study. Stellar initial results during the
first 20 procedures were submitted for publication to a leading
Electrophysiology journal, with the authors documenting 100% acute
efficacy and no adverse events. These results were included in the
regulatory submissions.
The CE Mark and PMA Supplement submissions of
the MAGiC catheter reflect the culmination of an extensive design,
development, manufacturing and testing effort. The catheter is the
first in a series of interventional devices being developed by
Stereotaxis and serves as a platform for future innovations.
Stereotaxis anticipates making the MAGiC catheter commercially
available for the community of robotic electrophysiologists
following receipt of regulatory clearances.
“We are excited to have reached this significant
milestone for Stereotaxis and for the physician community that is
pioneering the frontiers of robotics in electrophysiology,” said
David Fischel, Stereotaxis Chairman and CEO. “We look forward to
working collaboratively with the regulatory agencies during their
review of our submissions and hope to make the benefits of MAGiC
available to patients and physicians in the near future.”
About StereotaxisStereotaxis
(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 100,000 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, 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. FischelChairman and Chief Executive Officer
Kimberly R.
Peery Chief
Financial Officer
314-678-6100Investors@Stereotaxis.com
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