Stereotaxis Receives CE Mark Approval for the MAGiC Ablation Catheter
27 Gennaio 2025 - 2:00PM
Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical
robotics for minimally invasive endovascular intervention, today
announced that it received European CE Mark approval for the MAGiC™
ablation catheter. This approval is a significant milestone for
Stereotaxis and for the community of physicians pioneering robotics
in electrophysiology. It is reflective of the company’s commitment
to advancing significant innovations that make robotics
increasingly impactful across interventional medicine.
Stereotaxis’ MAGiC catheter is a
robotically-navigated magnetic ablation catheter designed to
perform cardiac ablation procedures that treat heart arrhythmia.
The MAGiC catheter was developed based on insights collected over
the course of nearly 20 years and 150,000 robotic ablation
procedures performed using predecessor catheters. The MAGiC
catheter is designed to enhance treatment precision and control
during cardiac ablation, while maintaining the intrinsic safety
advantage of a soft flexible catheter. It builds upon existing
benefits of robotic cardiac ablation with design enhancements that
include:
- Optimized Navigation, Force
& Stability – The unique placement of magnets and
design of the distal section of the catheter supports intuitive
navigation, consistent contact forces, and enhanced stability.
- Improved Data &
Information – MAGiC is available with iConnect and the
eContact module, offering catheter tissue contact information as
well as clear electrogram and responsive temperature data to
support physician decision making.
- Efficient Low-Flow Uniform
Cooling – Cooling of the tip is accomplished with low-flow
irrigation that substantially reduces overall fluid load on
patients while protecting against char and coagulation.
The MAGiC catheter has been approved in Europe
with a broad label that includes the delivery of “local lesions in
cardiac tissue for the treatment of cardiac arrhythmias.” Obtaining
the CE Mark follows years of effort and substantial investments in
catheter development, testing, manufacturing, and preclinical and
clinical research. Clinical experience with MAGiC in an ongoing
clinical study in Europe supports expectations for broad adoption
of MAGiC across robotic users.
“We are thrilled to announce this significant
milestone and introduce the MAGiC catheter to European physicians
and patients,” said David Fischel, Stereotaxis Chairman and CEO.
“We want to thank and recognize the significant contributions from
clinicians who guided us throughout the development efforts and
team members of Stereotaxis and Osypka that made this possible. We
look forward to seeing MAGiC serve as one of the key pillars in our
effort to make robotics broadly impactful and beneficial in
electrophysiology and endovascular surgery.”
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 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, 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, statements relating to our recent acquisition of APT,
including any benefits expected from the acquisition, 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.
Stereotaxis Contacts: David L.
FischelChairman and Chief Executive Officer
Kimberly PeeryChief Financial Officer
314-678-6100Investors@Stereotaxis.com
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