Magbot Robotic Magnetic Navigation Ablation Catheter Approved by China’s NMPA
December 09 2024 - 7:25AM
Stereotaxis (NYSE: STXS) and Shanghai MicroPort EP Medtech Co.,
Ltd. (688351.SH, “MicroPort EP”), today announced that the Magbot™
Magnetic Navigation Ablation Catheter has received regulatory
approval from China’s National Medical Products Administration
(NMPA).
The Magbot™ Catheter is a single-use magnetic
saline-irrigated radiofrequency ablation catheter designed and
developed by MicroPort EP in collaboration with Stereotaxis. The
catheter works exclusively and in tight conjunction with
Stereotaxis’ robotic systems, including the recently NMPA-approved
Genesis RMN™, and MicroPort EP’s Columbus™ 3D EP Mapping
System.
Magbot™ incorporates advanced design features
that substantially enhance the efficiency, effectiveness, and
safety of robotic magnetic catheter ablation. Robotically navigated
using low-intensity magnetic fields, the Magbot™ catheter is able
to reach areas of the heart otherwise difficult to access with
traditional methods and to maintain precise positioning and
stability on cardiac anatomy with millimeter-level accuracy. Full
integration with Columbus™ enables real-time location tracking and
3D cardiac modeling, allowing physicians to accurately record
electrocardiographic data and pinpoint lesions for precise
diagnosis and treatment of arrhythmias. A unique six-electrode
design enhances safety during procedures by offering visibility of
the catheter shaft without the need for fluoroscopy. Magbot™ has
been approved by NMPA for the ablation of drug-resistant persistent
atrial fibrillation, atrioventricular nodal reentrant tachycardia,
and atrioventricular reentrant tachycardia.
“The approval of the Magbot™ Catheter signifies
a major breakthrough for MicroPort EP in cardiac electrophysiology
and a significant milestone for robotic navigation technology in
China,” emphasized Dr. Yiyong Sun, President of MicroPort EP. “Our
recent technological advances with Stereotaxis offer a safer and
more precise minimally-invasive treatment solution for complex
arrhythmia patients. We are excited about its potential to benefit
physicians and patients alike and to strengthen our partnership
with Stereotaxis to drive innovation in electrophysiology.”
“We are delighted by Magbot™ approval in China,”
added David Fischel, Chairman and CEO of Stereotaxis. “This
milestone reflects our commitment to improving global
cardiovascular care. Magbot™ represents a key innovation in robotic
navigation, and we look forward to continuing our collaboration
with MicroPort EP to pioneer innovative technologies that advance
electrophysiology and benefit patients worldwide.”
MicroPort EP will initiate commercial launch of
Magbot™ in China through its existing sales team focused on the
electrophysiology community. Stereotaxis shares in the proceeds
from Magbot™ adoption. MicroPort EP is one of China’s leading
medical device companies with a portfolio of cardiovascular medical
devices designed to diagnose and treat arrythmias. Stereotaxis and
MicroPort EP previously announced their collaboration in August
2021.
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.
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constitute "forward-looking" statements, usually containing the
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differences include, but are not limited to, the Company's ability
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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 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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