Corindus Announces First Patient Enrolled in PRECISION GRX Registry
September 12 2017 - 6:45AM
Business Wire
Multicenter Post-Market Registry Designed to
Collect Data on Routine use of the CorPath® GRX System
Corindus Vascular Robotics, Inc. [NYSE American: CVRS], a
leading developer of precision vascular robotics, today announced
first patient enrollment in the PRECISION GRX Registry, a
post-market study to continue market surveillance of the Company's
second generation CorPath GRX System.
The PRECISION GRX Registry will include up to 25 sites and
enroll up to 1,000 patients receiving robotic-assisted percutaneous
coronary intervention (PCI). The study will gather data to evaluate
patient outcomes, potential economic benefits, procedural
parameters and the expanding capabilities of robotics in PCI.
Additional sub-studies will seek to evaluate the impact of robotics
on left transradial access and robotic wiring times. Dr. Ehtisham
Mahmud, Division Chief of UC San Diego Health, Cardiovascular
Medicine and Medical Director, Sulpizio Cardiovascular Center, has
been named as the Global Principal Investigator for the PRECISION
GRX Study.
"We have shown that robotic-assisted PCI can be used with high
clinical and technical success in multiple sites with multiple
operators and the new Registry is designed to evaluate the impact
of the expanding capabilities of robotics," said Ehtisham Mahmud,
MD. "I look forward to spearheading the effort in evaluating this
new technology and its value in current practice."
The procedure on the first patient in the trial was performed by
Dr. Srini Potluri at The Heart Hospital Baylor Plano, one of two
Baylor hospitals participating in the Registry. The hospital
currently has two CorPath GRX Systems installed in its
catheterization labs. Dr. Potluri stated, "I am excited to
participate in the PRECISION GRX Registry to expand the depth of
clinical research supporting robotic-assisted PCI. Our
participation emphasizes our continuous commitment to advancing
patient care in interventional medicine."
"Enrollment of the first patient in the PRECISION GRX Registry
is a major milestone for the Company and we look forward to the
participation of leading centers across the country," said Mark
Toland, President and Chief Executive Officer of Corindus. "We
strongly believe that the improvements to the CorPath platform with
GRX will further validate the widespread benefits and adoption of
robotic-assisted PCI."
About Corindus Vascular Robotics, Inc.
Corindus Vascular Robotics, Inc. is a global technology leader
in robotic-assisted vascular interventions. The company's CorPath®
System is the first FDA-cleared medical device to bring robotic
precision to percutaneous coronary interventions. During the
procedure, the interventional cardiologist sits at a
radiation-shielded workstation to advance guide catheters, stents,
and guidewires with millimeter-by-millimeter precision. The
workstation allows the physician greater control and the freedom
from wearing heavy lead protective equipment that causes
musculoskeletal injuries. With the CorPath System, Corindus
Vascular Robotics brings robotic precision to interventional
procedures to help optimize clinical outcomes and minimize the
costs associated with complications of improper stent placement
during manual procedures. Corindus stands behind its product with
its unique $1,000 hospital credit "One Stent Program." For
additional information, visit www.corindus.com, and follow
@CorindusInc.
Forward Looking Statements
Statements made in this release that are not statements of
historical or current facts are "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements may involve known and unknown
risks, uncertainties and other factors that may cause the actual
results, performance or achievements of Corindus to be materially
different from historical results or from any future results or
projections expressed or implied by such forward-looking
statements. Accordingly, readers should not place undue reliance on
any forward looking statements. In addition to statements that
explicitly describe such risks and uncertainties, readers are urged
to consider statements in the conditional or future tenses or that
includes terms such as "believes," "belief," "expects,"
"estimates," "intends," "anticipates" or "plans" to be uncertain
and forward-looking. Forward-looking statements may include
comments as to Corindus’ beliefs and expectations as to future
events and trends affecting its business and are necessarily
subject to uncertainties, many of which are outside Corindus’
control.
An example of such a statement is that:
- the PRECISION GRX Study will include up
to 25 sites, enroll up to 1,000 patients receiving PCI, and will
gather data to evaluate patient outcomes, potential economic
benefits, procedural parameters and the expanding capabilities of
robotics in PCI, with additional sub-studies seeking to evaluate
the impact of robotics on left transradial access and robotic
wiring times;
- the new Registry is designed to
evaluate the impact of the expanding capabilities of robotics and
the effort in evaluating this new technology and its value in
current practice; and
- Corindus' belief that the improvements
to the CorPath platform with GRX will further validate the
widespread benefits and adoption of robotic-assisted PCI.
Important factors that could cause actual results to differ
materially from those indicated by such forward-looking statements
are described in the sections titled "Risk Factors" in the
company's filings with the Securities and Exchange Commission,
including its most recent Annual Report on Form 10-K and Quarterly
Reports on Form 10-Q, as well as reports on Form 8-K, including,
but not limited to the following: the rate of adoption of our
CorPath System and the rate of use of our cassettes; risks
associated with market acceptance, including pricing and
reimbursement; our ability to enforce our intellectual property
rights; our need for additional funds to support our operations;
our ability to manage expenses and cash flow; factors relating to
engineering, regulatory, manufacturing, sales and customer service
challenges; potential safety and regulatory issues that could slow
or suspend our sales; and the effect of credit, financial and
economic conditions on capital spending by our potential customers.
Forward looking statements speak only as of the date they are made.
Corindus undertakes no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise that occur after that date. More
information is available on Corindus' website at
http://www.corindus.com.
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version on businesswire.com: http://www.businesswire.com/news/home/20170912005281/en/
Corindus Vascular Robotics, Inc.Media Contact:Kate
Stanton, 508-653-3335 ext.
200kate.stanton@corindus.comorInvestor Contact:Lynn Pieper
Lewis, 415-937-5402ir@corindus.com
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