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Stereotaxis Announces European Adoption Milestone and Health Canada
Market Clearance for VdriveT System
ST. LOUIS, Feb. 8, 2012 /PRNewswire/ -- Stereotaxis, Inc. (NASDAQ:
STXS) today announced that its VdriveT Robotic Navigation System,
which provides physicians the ability to remotely manipulate
traditionally non-robotic catheters, is growing in popularity and is
expected to surpass 500 clinical procedures in Europe in February.
The company also announced it has received regulatory clearance from
Health Canada to commercially market the device in Canada.
Since the initial product release in Europe in 2011, the Vdrive system
has been installed in nine centers, with units scheduled to be
installed in additional centers during the first quarter of 2012. The
initial nine centers have performed 473 clinical cases with
approximately 80% being completed in the left atrium of the heart.
Numerous cases have been performed with the VdriveT system and
clinical feedback continues to be very positive," said Michael P.
Kaminski, President and CEO of Stereotaxis. "With the Health Canada
market clearance for the Vdrive system, and our planned new Vdrive
installations in Europe and Canada this year, we are well-positioned
to drive the growth and further adoption of this exciting technology
in electrophysiology labs in these important markets."
In a fully remote procedure environment, the Vdrive system increases
the clinical techniques available to the physician and reduces the
need to re-enter the sterile field to adjust devices. Initial
clinical data from European physicians demonstrates that this
simplification saves 30 minutes(1) or more in robotic procedures,
depending on the individual clinical technique. Furthermore, the
addition of robotic diagnostic catheter manipulation is another step
in Stereotaxis' vision to improve device control. Stereotaxis' broad
EpochT solutions portfolio also includes precise magnetic control of
ablation catheters with Niobe@ ES and integrated display and control
of multiple lab technologies with the OdysseyT Clinical Information
The design of the Vdrive system allows the robotic hardware to adapt
to different clinical techniques depending on the disposable adaptor
that is attached to the arm:
-- V-LoopT circular catheter manipulator allows control of circular
diagnostic catheters, primarily in left atrial procedures.
-- V-CAST catheter advancement system allows advancement and
retraction of the magnetic catheter as well as robotic manipulation of
catheter introducer sheaths that are already in use during the
-- V-CAS DeflectT catheter advancement system is a more advanced
device that includes an integrated robotic deflectable sheath.
Initial positive results from multiple physician users confirmed the
significant clinical value delivered by the Vdrive system related to
-- Dr. Georg Noelker of the Herz- und Diabeteszentrum NRW in Bad
Oeynhausen, Germany commented on the V-Loop system: "We have adopted
Vdrive for navigating the circular mapping catheter for all of our
left atrial procedures. Our initial experience with Vdrive has shown
that we can reduce our left atrial procedures times by approximately
30%, and can further reduce our fluoroscopy times by an additional 14%
over our previous times with magnetic navigation alone."
-- Dr. Xu Chen of the Rigshospitalet in Copenhagen commented on the
V-CAS system: "The addition of robotic sheath control to a magnetic
procedure allows me to efficiently access even challenging areas of
the heart chambers and focus on patient therapy instead of catheter
control. The Vdrive control was intuitive and did not take long to
implement as a part of my procedure. In difficult cases the Vdrive
control even reduced my total procedure time."
-- Dr. Petr Neuzil of Homolce Hospital in Prague shared his
perspective on the V-CAS Deflect system: "The advancements in the
Vdrive technology use the best of previous magnetic and robotic
systems to provide a new level of catheter control, which is expected
to improve outcomes in ablation procedures."
The regulatory milestone in Canada covers both the V-Loop circular
catheter manipulator and the V-CAS catheter advancement system with
sheath manipulator. The Company's 510(k) submission for the V-Loop
circular catheter manipulator is under review by the U.S. Food and
(1) Stereotaxis data on file
About Stereotaxis www.stereotaxis.com www.odysseyexperience.com
Stereotaxis designs, manufactures and markets an advanced cardiology
instrument control system for use in a hospital's interventional
surgical suite to enhance the treatment of coronary artery disease and
arrhythmias. The Niobe@ Remote Magnetic Navigation System is designed
to enable physicians to complete more complex interventional
procedures by providing image guided delivery of catheters and
guidewires through the blood vessels and chambers of the heart to
treatment sites. This is achieved using computer-controlled,
externally applied magnetic fields that govern the motion of the
working tip of the catheter or guidewire, resulting in improved
navigation and reduced x-ray exposure.
Stereotaxis' OdysseyT portfolio of products provides an innovative
enterprise solution for integrating, recording and networking
interventional lab information within hospitals and around the world.
OdysseyT Vision integrates data for magnetic and standard
interventional labs, enhancing the physician workflow through a
consolidated display of multiple systems and eliminating the challenge
of interacting simultaneously with many separate diagnostic systems.
The Odyssey CinemaT Studio then captures a complete record of
synchronized procedure data that can be viewed live or from a
comprehensive archive of cases performed. OdysseyT solution then
enables hospitals to efficiently share live and recorded clinical data
anywhere around the world to attract patients and promote
The core components of the Stereotaxis systems have received
regulatory clearance in the U.S., Europe, Canada and elsewhere. For
more information, please visit www.stereotaxis.com and
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, 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 our systems and the timing of such purchases, our continued
access to capital and financial resources, including our ability to
negotiate financing and lending arrangements on terms that are
acceptable, the outcome of various shareholder litigation recently
filed against us, 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.
SOURCE Stereotaxis, Inc.
/CONTACT: Sam Duggan, Chief Financial Officer, +1-314-678-6007, or Media, Frank Cheng, Senior Vice President, Marketing & Business Development, +1-314-678-6111, both of Stereotaxis, Inc.; or Investors, Gregory Gin, +1-646-445-4801, or Doug Sherk, +1-415-568-4887, both of EVC Group, Inc., for Stereotaxis, Inc.
/Web Site: http://www.stereotaxis.com
CO: Stereotaxis, Inc.
ST: Missouri Canada
IN: HEA MTC MEQ CPR
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