Stereotaxis Receives FDA Clearance of Vdrive(R) With V-CAS(TM) System Along With Regulatory Approval of Odyssey(R) System in ...
January 05 2015 - 6:30AM
Stereotaxis, Inc. (Nasdaq:STXS) announced today that it has
received 510(k) clearance by the Food and Drug Administration (FDA)
for its Vdrive® with V-CAS™ Catheter Advancement System in the
U.S., representing the Company's third Vdrive system product to be
cleared for market entry. The Company also announced that it has
received regulatory approval of its Odyssey® product line by the
Japan Pharmaceuticals and Medical Devices Agency, the country's
equivalent to the U.S. FDA.
Stereotaxis' Vdrive with V-Loop™ Variable Loop Catheter
Manipulator received U.S. clearance in September 2014 and its
Vdrive with V-Sono™ Intracardiac Echocardiography Catheter
Manipulator has been available since 2013.
"The Vdrive system and disposable suite provides flexibility in
robotic catheter and sheath control, adaptable to a physician's
individual workflow and product preferences," said William C.
Mills, Stereotaxis Chief Executive Officer. "As additional Vdrive
system accessories gain market approval in the U.S., we move closer
to our vision of a fully remote electrophysiology procedure
environment."
The Vdrive with V-CAS system, which was first released in Europe
in 2011, allows physicians to remotely control the advancement,
retraction and rotation of a compatible fixed curve transseptal
sheath, in conjunction with a magnetic ablation catheter. Utilized
in the majority of ablation procedures, the fixed curve transseptal
sheath provides stability and support to the ablation catheter
during therapy delivery.
Bruno Schwagten, M.D., Ph.D. at ZNA Middelheim Hospital in
Belgium, who has performed Stereotaxis magnetic navigation
procedures since 2008 and started using the Vdrive with V-CAS
system in 2012, said, "The addition of robotic sheath control to a
magnetic procedure has simplified the therapy process and enhanced
patient safety, allowing me to efficiently access even the most
challenging areas of the heart chambers."
In Japan, approval of the Stereotaxis Odyssey Vision™ system for
use in conjunction with the Niobe® ES remote magnetic navigation
system comes three months after the Company's first commercial
order in that country. The Odyssey Vision system, together with the
Odyssey Cinema™ solutions, provides a consolidated user interface
of all lab information during a Niobe procedure, as well as
real-time or recorded viewing of procedures across networks and
institutions. The Company expects to submit its Vdrive system for
regulatory review in Japan during the first quarter of 2015.
About Stereotaxis
Stereotaxis 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® ES remote magnetic navigation system, the
Odyssey® portfolio of lab optimization, networking and patient
information management systems and the Vdrive™ robotic navigation
system and consumables.
The core components of Stereotaxis systems have received
regulatory clearance in the U.S., 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 U.S. clearance. 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 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 U.S., 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.
CONTACT: Investor Contact:
Martin Stammer
Chief Financial Officer
314-678-6155
Investor Contact:
Todd Kehrli / Jim Byers
MKR Group, Inc.
323-468-2300
stxs@mkr-group.com