PLC Medical Systems to Introduce RenalGuard(TM) at TCT 2007
2007年10月22日 - 9:30PM
PRニュース・ワイアー (英語)
RenalGuard - An Innovative Approach to Preventing Kidney Damage
during Imaging Procedures FRANKLIN, Mass., Oct. 22
/PRNewswire-FirstCall/ -- PLC Systems Inc. (AMEX:PLC), a company
focused on innovative cardiac and vascular medical device-based
technologies, announced today that it will introduce the RenalGuard
System(TM) at TCT 2007, sponsored by the Cardiovascular Research
Foundation, October 20-25, 2007, in Washington, DC. This is the
first public showing for this technology in the United States.
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, when undergoing
cardiovascular imaging procedures. RenalGuard Therapy(TM) is based
on initial 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 the at-risk
segment of the millions of interventional cardiology and radiology
patients undergoing these procedures. "We are very pleased to have
the opportunity to introduce our innovative RenalGuard System at
TCT 2007 this year," stated Mark R. Tauscher, President and CEO of
PLC Systems Inc. "TCT is one of the most important meetings in the
field of Interventional Cardiology. They have been a leader in
bringing the issues of CIN to the medical community. This will be
an excellent opportunity for us to meet with a large number of
interventional cardiologists who are potential investigators, and
we are looking forward to the feedback we will receive on
RenalGuard Therapy and the RenalGuard System." Earlier this year,
the company announced the successful enrollment of the first
patients in its FDA-approved pilot 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 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 is
currently conducting a pilot clinical safety study of its
RenalGuard Therapy and RenalGuard System. 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," "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 June 30,
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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