Paracelsus Medical University Clinical Study on Stereotaxis Technology Benefits Recognized at European Cardiac Arrhythmia Soc...
01 June 2016 - 11:00PM
Stereotaxis, Inc. (NASDAQ:STXS), a global leader in innovative
technologies for the treatment of cardiac arrhythmias, today
announced the results of a retrospective study conducted at
Paracelsus Medical University in Nuremberg, Germany, which showed
significantly reduced radiation exposure for patients undergoing
catheter ablation for persistent atrial fibrillation (AF) with the
Niobe® magnetic navigation system. The study received first place
honors for “Best Poster Presentation” at the European Cardiac
Arrhythmia Society Congress in Paris.
“We utilize the Niobe system daily and trust it implicitly to
improve the safety and efficacy of ablation procedures for atrial
fibrillation, ventricular tachycardia and other complex cases,”
said Dirk Bastian, MD, electrophysiology specialist at Paracelsus
Medical University, Nuremberg. “The data collected from these
procedures further demonstrate the significantly reduced
fluoroscopy times that can be achieved through the Niobe system’s
remote navigation and image integration capabilities, minimizing
radiation exposure to both the patient and operator, and also
reflect excellent acute and long-term results with minimal
complications. We are very pleased to share these important
findings as we continue our pledge to provide the highest patient
care through innovative medical technologies.”
The study analyzed data on 169 patients with symptomatic,
persistent AF undergoing catheter ablation with the Niobe system,
documenting fluoroscopy time for system calibration, transseptal
access/catheter positioning and mapping/ablation. Total fluoroscopy
time was 5.1±3.8 minutes, compared to an average of 14 to >60
minutes reported for traditional manual ablation procedures, and
the effective radiation dose was 0.61±0.9 millisieverts (mSv)
compared to the typical mean effective dose of 16.6 mSv reported
for manual procedures, representing a 96% reduction.
The Nuremberg hospital, one of the largest in Europe, installed
the Niobe system as part of its new Heart-Vascular Center. Konrad
Göhl, MD and Dirk Bastian, MD were trained on the Niobe system in
2011 and have completed more than 1,000 ablation procedures on the
remote magnetic navigation platform. The department of
electrophysiology will complete the 12 month follow-up on
approximately 600 patients undergoing AF ablation with the Niobe
system and analyze the data regarding efficacy, safety and
radiation exposure for the total population as well as several
subgroups (Remote MAGNetic Catheter Ablation for Atrial
Fibrillation – MAGNA-AF, ClinicalTrials.gov Identifier:
NCT02587624).
About StereotaxisStereotaxis is a healthcare
technology and innovation leader in the development of robotic
cardiology instrument navigation systems designed to enhance the
treatment of arrhythmias and coronary disease, as well as
information management solutions for the interventional lab. Over
100 issued patents support the Stereotaxis platform, which helps
physicians around the world provide unsurpassed patient care with
robotic precision and safety, improved lab efficiency and
productivity, and enhanced integration of procedural information.
Stereotaxis' core Epoch® Solution includes the Niobe® magnetic
navigation system, the Odyssey® portfolio of lab optimization,
networking and patient information management solutions, and the
Vdrive® robotic navigation system and consumables.
The core components of Stereotaxis’ systems have received
regulatory clearance in the United States, European Union, Canada,
China, Japan, and elsewhere. The V-Sono™ ICE catheter manipulator,
V-Loop™ variable loop catheter manipulator, and V-CAS™ catheter
advancement system have received clearance in the United States,
Canada, and the European Union. 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
from the forward-looking statements. Factors that would cause or
contribute to such differences include, but are not limited to, the
Company's ability to raise additional capital on a timely basis and
on terms that are acceptable, its continued listing on the NASDAQ
Capital Market, its ability to continue to manage expenses and cash
burn rate at sustainable levels, its ability to continue to work
with lenders to extend, repay or refinance indebtedness on
acceptable terms, continued 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 systems and
the timing of such purchases, competitive factors, changes
resulting from the recently enacted healthcare reform in the United
States, including changes in government reimbursement procedures,
dependence upon third-party vendors, timing of regulatory
approvals, 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 in any particular period or at all because some
of these purchase orders and other commitments are subject to
contingencies that are outside of the Company's control. In
addition, these orders and commitments may be revised, modified,
delayed or canceled, either by their express terms, as a result of
negotiations, or by overall project changes or delays.
Company Contact:
Martin C. Stammer
Chief Financial Officer
314-678-6155
Investor Contact:
Todd Kehrli / Jim Byers
MKR Group, Inc.
323-468-2300
stxs@mkr-group.com