Stereotaxis Announces CE Mark Submission for Robotically Navigated MAGiC Ablation Catheter
11 Juillet 2022 - 03:08PM
GlobeNewswire Inc.
Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical
robotics for minimally invasive endovascular intervention, today
announced the CE Mark submission for its MAGiC™ catheter. The MAGiC
catheter is a robotically navigated magnetic interventional
ablation catheter for minimally invasive cardiac ablation
procedures. Used in conjunction with Stereotaxis’ robotic systems,
the MAGiC catheter is designed to provide unparalleled catheter
precision, stability and flexibility when diagnosing and treating
cardiac arrhythmias.
Building on over 100,000 procedures and nearly
twenty years of experience gained from existing robotically
navigated ablation catheters, MAGiC has been developed in
collaboration with Osypka, a German medical devices company that
pioneered the development of radiofrequency ablation of cardiac
arrhythmias. MAGiC incorporates various features that are designed
to enhance patient safety and efficacy, procedural efficiency, and
the physician experience.
“The electrophysiology community has long
awaited innovation in robotic catheter technology, and we are very
excited by the near-term availability of the MAGiC catheter,” said
Prof. Sabine Ernst, Cardiologist at Royal Brompton & Harefield
Hospitals and Professor of Practice in Cardiology at Imperial
College London. “I believe MAGiC will be a significant leap forward
in clinical care for my patients and improved robotic
performance.”
CE Mark submission of the MAGiC catheter
reflects the culmination of an extensive design, development,
manufacturing and testing effort. This 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
robotic electrophysiology practices in Europe following receipt of
CE Mark as early as year’s end. Stereotaxis separately continues to
work toward the submission of an application to the FDA to initiate
a prospective IDE trial in the United States.
“We are very pleased to reach this important
milestone. This is a seminal event for Stereotaxis as a company and
for the physician community that is pioneering the frontiers of
robotics in electrophysiology.” said David Fischel, Stereotaxis
Chairman and CEO. “Our attention is focused on preparing for
commercial launch of the catheter once we receive regulatory
clearance. We look forward to the positive impact MAGiC can have on
patients, physicians, providers and medical progress.”
About StereotaxisStereotaxis 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,
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.
Investor Contacts: |
Media
Contact: |
David L. Fischel |
Bethanne Schluter |
Chairman and Chief Executive Officer |
Director, Marketing & Communications |
|
314-678-6213 |
Kimberly Peery |
B.Schluter@Stereotaxis.com |
Chief Financial Officer |
|
|
|
314-678-6100 |
|
Investors@Stereotaxis.com |
|
Photos accompanying this announcement are available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/0601c262-27e0-4bed-a86e-36199cc54b55
https://www.globenewswire.com/NewsRoom/AttachmentNg/97cc4b8f-00b8-4f32-9652-3f83f778a412
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