Journal of American College of Cardiology Publishes Pioneering Study Using Stereotaxis Robotic Technology to Treat Pulmonary ...
August 26 2020 - 9:05AM
Stereotaxis (NYSE: STXS), the global leader in innovative robotic
technologies for the treatment of cardiac arrhythmias, today
announced a pioneering publication in the prestigious Journal of
the American College of Cardiology (JACC) on the use of
Stereotaxis’ robotic technology to treat pulmonary hypertension.
Dr. Alexander Romanov and colleagues at the
National Medical Research Center in Novosibirsk, Russia led an
investigator-initiated 50-patient, prospective, randomized,
blinded, sham-controlled study of pulmonary artery denervation
using Robotic Magnetic Navigation for patients with chronic
thromboembolic pulmonary hypertension (CTEPH) after pulmonary
endarterectomy. CTEPH is a severe form of pulmonary hypertension
caused by blood clots that don’t dissolve in the lungs leading to
progressive right heart failure. In the study, denervation of the
pulmonary arteries was performed using a robotically-navigated
ablation catheter. Patients receiving this treatment compared
favorably across all efficacy and safety endpoints to those that
received a sham procedure and were treated with best pharmaceutical
care. At 12 months post-procedure, pulmonary vascular resistance
was lower (p=0.001), pulmonary artery pressure was reduced
(p=0.01), patients performed better on a 6-minute walk test
(p=0.03), and hospitalization due to heart failure was reduced by
86% (p=0.049).
“Our results demonstrate that pulmonary artery
denervation may serve as an important new therapy for residual
chronic thromboembolic pulmonary hypertension,” said Dr. Romanov.
“The use of robotic technology enables the success of such
procedures by enhancing catheter precision and safety. We are proud
to be pioneering new therapies that can improve medical care and
hope that this technology will be further tested in patients with
different types of pulmonary hypertension.”
“We are delighted to see the strength of
clinical benefits shown in this pioneering study,” said David
Fischel, Stereotaxis Chairman and CEO. “We have long known that
Robotic Magnetic Navigation can broadly improve and enable
interventional medicine. Pulmonary hypertension remains a disease
with significant unmet medical need, and this therapy offers
potential promise in one of the first non-arrhythmia indications
for Stereotaxis to pursue.”
The publication can be found at
https://www.onlinejacc.org/content/76/8/916. An editorial
commenting on the publication can be found in the same journal at
https://www.onlinejacc.org/content/76/8/927. To access the complete
database of more than 400 scientific publications referencing
Stereotaxis technology, visit
www.RoboticEP.com/clinical-data/publications-database/.
About StereotaxisStereotaxis is
the global leader in innovative robotic technologies designed to
enhance the treatment of arrhythmias and perform endovascular
procedures. 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,
improved lab efficiency and productivity, and enhanced integration
of procedural information. The core components of Stereotaxis’
systems have received regulatory clearance in the United States,
European Union, Japan, Canada, China, and elsewhere. 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 continue to manage expenses
and cash burn rate at sustainable levels, 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 healthcare policy in the United
States, including changes in government reimbursement of
procedures, dependence upon third-party vendors, timing of
regulatory approvals, the impact of the recent coronavirus
(COVID-19) pandemic and our response to it, 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 Contacts:David L.
FischelChairman and Chief Executive Officer
Kimberly PeeryChief Financial Officer
314-678-6100investors@stereotaxis.com
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