PLC Medical Systems to Demonstrate RenalGuard(TM) at EuroPCR 2008
2008年5月12日 - 9:01PM
PRニュース・ワイアー (英語)
FRANKLIN, Mass., May 12 /PRNewswire-FirstCall/ -- PLC Systems Inc.
(AMEX:PLC), a company focused on innovative cardiac and vascular
medical device-based technologies, announced today that it will
demonstrate its RenalGuard System(TM) at EuroPCR, the annual
meeting of the European Association of Percutaneous Cardiovascular
Interventions (EAPCI), May 12-16, 2008, in Barcelona, Spain. More
than 11,000 clinicians and professionals are expected to attend
this event. RenalGuard(TM) is based on existing pre-clinical study
data that suggests that initiating and maintaining high urine
output during imaging procedures allows the body to rapidly
eliminate toxins in contrast media, reducing their harmful effects.
RenalGuard is a fully-automated, real-time matched fluid
replacement device intended for interventional cardiology and
radiology patients undergoing imaging procedures using contrast
media. "We are very pleased to have the opportunity to demonstrate
our innovative RenalGuard System at EuroPCR this year and increase
awareness about what can be done to mitigate the potentially
harmful effects of contrast media on compromised patients who
require imaging procedures," stated Mark R. Tauscher, President and
CEO of PLC Systems Inc. "We look forward to the feedback we will
receive on RenalGuard from the international medical community,
especially the European market. PLC received the CE Mark
Certificate for the RenalGuard System in late December 2007, and
concluded its pilot safety trial in the U.S. late in 2007. The
company has received conditional approval from the FDA to commence
a U.S. pivotal trial to study the effectiveness of RenalGuard in
the prevention of CIN. In March 2008, PLC signed its first
international distribution agreement for RenalGuard with Artech
s.r.l., Cavezzo, Italy for distribution of its RenalGuard System
into Italy. Contrast-Induced Nephropathy Approximately seven
million patients worldwide undergo interventional cardiovascular
therapeutic and diagnostic imaging procedures each year.
Contrast-Induced Nephropathy, or CIN, is a major and growing
problem due to the increasing number of older patients, diabetics
and patients with pre- existing renal failure - all of whose
conditions make them at risk for CIN when they require
interventional procedures that use radiographic contrast media. CIN
is the third most common cause of in-hospital acute renal failure.
It is associated with significant in-hospital mortality rates, and
increases in long-term mortality rates, major in-hospital adverse
cardiac events, and the risk of having to undergo renal dialysis
therapy. Any of these can result in prolonged hospital stays and
increased medical costs. Studies indicate that approximately 15-20%
of all patients undergoing image-guided cardiology and radiology
procedures are at risk of developing CIN. The estimated mortality
rate for patients that acquire CIN may be as high as 35%. About PLC
Systems Inc. PLC Systems Inc. is a medical technology company
specializing in innovative technologies for the cardiac and
vascular markets. Headquartered in Franklin, Mass., PLC pioneered
the CO2 Heart Laser System, which cardiac surgeons use to perform
CO2 transmyocardial revascularization (TMR) to alleviate symptoms
of severe angina. CO2 TMR offers a treatment option for angina
patients who suffer from severe coronary artery disease. The CO2
Heart Laser is the world's first TMR angina relief device cleared
for commercial distribution by both the U.S. Food and Drug
Administration and Japanese Ministry of Health, Labor and Welfare,
and to obtain a CE Mark for European distribution. The company
completed a pilot clinical safety study of its RenalGuard
Therapy(TM) and RenalGuard System and has received its CE Mark
Certificate for RenalGuard System. PLC recently received FDA
conditional approval to commence a U.S. pivotal trial to study the
effectiveness of its RenalGuard Therapy and Renal Guard System in
the prevention of Contrast-Induced Nephropathy (CIN). RenalGuard
Therapy is designed to reduce the toxic effects that contrast media
can have on the kidneys. This therapy is based on the theory that
creating and maintaining a high urine output is beneficial to
patients undergoing imaging procedures where contrast agents are
used. The real-time measurement and matched fluid replacement
design of the RenalGuard System is intended to ensure that a high
urine flow is maintained before, during and after these procedures.
This should allow the body to rapidly eliminate contrast, reducing
its toxic effects. The RenalGuard System, with its matched fluid
replacement capability, is intended to minimize the risk of over-
or under-hydration. Additional company information can be found at
http://www.plcmed.com/. This press release contains
"forward-looking" statements. For this purpose, any statements
contained in this press release that relate to prospective events
or developments are deemed to be forward-looking statements. Words
such as "believes," "anticipates," "plans," "expects," "will" and
similar expressions are intended to identify forward-looking
statements. Our statements of our objectives are also
forward-looking statements. While we may elect to update
forward-looking statements in the future, we specifically disclaim
any obligation to do so, even if our estimates change, and you
should not rely on these forward-looking statements as representing
our views as of any date subsequent to the date of this press
release. Actual results could differ materially from those
indicated by such forward-looking statements as a result of a
variety of important factors, including that we may not receive
necessary regulatory approvals to market our RenalGuard product or
that such approvals may be withdrawn, the clinical trials for that
product may not be successful, the RenalGuard product may not be
commercially accepted, operational changes, competitive
developments may affect the market for our products, regulatory
approval requirements may affect the market for our products, and
additional risk factors described in our Report on Form 10-K for
the year ended December 31, 2007, and our other SEC reports. PLC
Systems, PLC Medical Systems, PLC and CO2 Heart Laser, RenalGuard,
RenalGuard Therapy and RenalGuard System are trademarks of PLC
Systems Inc. Contact: Mary T. Conway Conway Communications
617-244-9682 DATASOURCE: PLC Systems Inc. CONTACT: Mary T. Conway
of Conway Communications, +1-617-244-9682, Web site:
http://www.plcmed.com/
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