Stereotaxis Initiates Multi-Center Randomized Superiority Study on Ventricular Tachycardia Ablation Outcomes
January 11 2016 - 9:00AM
Stereotaxis, Inc. (NASDAQ:STXS), a global leader in innovative
technologies for the treatment of cardiac arrhythmias, today
announced that it has initiated its first prospective,
multi-center, randomized clinical study to compare radiofrequency
ablation outcomes generated using its Niobe® ES remote magnetic
navigation system to manual approaches in ischemic scar ventricular
tachycardia (VT) patients. VT is a rapid heart rhythm that, if left
untreated, may lead to ventricular fibrillation and sudden cardiac
death. It is estimated that approximately 60,000 ablations are
performed annually on a worldwide basis to treat VT, with that
number increasing by over 10% each year. In 2015,
approximately 2,300 of these 60,000 procedures were performed using
the Niobe system.
“The Niobe system is uniquely well-suited for the treatment of
arrhythmias in difficult-to-reach, complex anatomy, such as VT, and
has an outstanding performance record in safety, acute success and
long-term results with VT ablation,” said William C. Mills,
Stereotaxis Chief Executive Officer. “We believe this superiority
study will provide definitive evidence of the improved long-term
patient outcomes that physicians realize with the Niobe system in
treating VT compared to manual approaches.”
Researchers from U.S. and European sites will conduct a
prospective, post-market, randomized controlled trial involving 382
patients and designed to establish the superiority of VT ablation
outcomes using the Niobe ES system versus a manual approach in a
low ventricular ejection fraction population. The study, named the
“MAGNETIC VT” study, will be led by Global Principal Investigator
Dr. Andrea Natale, Executive Medical Director, Texas Cardiac
Arrhythmia Institute of St. David’s Medical Center, along with
Co-Principal Investigators Dr. Tamas Szili-Torok from Erasmus
Medical Center of the Netherlands, and Dr. Roderick Tung from The
University of Chicago Medicine. Ten hospitals have confirmed
participation. The study can be expanded to another five hospitals
at the discretion of the study’s sponsor and principal
investigators.
Dr. Natale and a group of U.S. physicians recently conducted a
multi-center, retrospective study comparing long-term success rates
with the Niobe system and manual approaches in VT. The
findings of that study revealed a substantially greater long-term
success rate among the Niobe patient group (81.2% vs. 69%) and were
published at the American Heart Association Scientific
Sessions.
“Finding the optimal treatment for VT is a very important
clinical topic, and the MAGNETIC VT study is one of the few
randomized clinical trials being conducted around the world that
can lead to meaningful insights on the topic. Through this upcoming
study, we have the opportunity to determine if treatment of VT with
the Niobe system is superior to manual approaches, which would
further support its classification as the standard of care,” said
Dr. Natale.
Patient enrollment is expected to begin shortly, with follow-up
occurring at three, six, nine and twelve months. The primary
endpoint is freedom from any recurrence of VT through one year.
Participating centers, each considered VT centers of excellence,
include:
- Advocate Christ Medical Center (Oak Lawn, IL)
- Algemeen Ziekenhuis (Brugge, Belgium)
- Erasmus Medical Center (Rotterdam, Netherlands)
- Medical College of Georgia (Augusta, GA)
- Intermountain Medical Center (Murray, UT)
- Nemocnice Na Homolce (Prague, Czech Republic)
- Rigshospitalet (Copenhagen, Denmark)
- St. David’s Medical Center (Austin, TX)
- The University of Chicago Medicine (Chicago, IL)
- The University of Kansas Hospital (Kansas City, KS)
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® 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 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 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.
STXS Company Contact:
Martin Stammer
Chief Financial Officer
314-678-6155
STXS Investor Contact:
Todd Kehrli / Jim Byers
MKR Group, Inc.
323-468-2300
stxs@mkr-group.com