PLC Medical Systems to Demonstrate RenalGuard(TM) at EuroPCR 2007
21 Maio 2007 - 10:00AM
PR Newswire (US)
RenalGuard - An Innovative Approach to Preventing Kidney Damage
During Imaging Procedures FRANKLIN, Mass., May 21
/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 the
RenalGuard System(TM) at EuroPCR, the annual meeting of the
European Association of Percutaneous Cardiovascular Interventions
(EAPCI), May 22-25, 2007, in Barcelona, Spain. RenalGuard(TM) is an
investigational system and therapy that targets patients with
compromised renal function who may be at risk for Contrast- Induced
Nephropathy, or CIN. RenalGuard Therapy(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. The RenalGuard System 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," stated Mark R. Tauscher, President and CEO of
PLC Systems Inc. "We look forward to the feedback we will receive
on RenalGuard Therapy and the RenalGuard System from the
international medical community, especially the European market."
In March, the company announced the successful enrollment of the
first patients in its FDA-approved clinical trial designed to
evaluate the safety of its RenalGuard System. Safety results were
favorable, and there were no adverse renal events related to the
device recorded. Contrast-Induced Nephropathy Approximately seven
million patients worldwide undergo interventional cardiovascular
therapeutic and diagnostic imaging procedures each year. 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 approved
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 recently initiated clinical studies for
its RenalGuard Therapy and RenalGuard System. RenalGuard's matched
fluid replacement system is designed for interventional cardiology
and radiology patients undergoing diagnostic and therapeutic
imaging procedures where contrast agents are administered.
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," "estimates," "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 we may not receive
necessary regulatory approvals to market our RenalGuard product,
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
Quarterly Report on Form 10-Q for the three months ended March 31,
2007, and our other reports filed with the Securities and Exchange
Commission. PLC Systems, PLC Medical Systems, PLC, CO2 Heart Laser,
RenalGuard, RenalGuard System and RenalGuard Therapy 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, , for PLC Systems Inc.
Web site: http://www.plcmed.com/
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