First Patients Treated In RenalGuard(TM) Investigational Study By PLC Medical Systems
2007年3月16日 - 10:05PM
PRニュース・ワイアー (英語)
Initial study designed to test safety of RenalGuard System(TM)
during Interventional Procedures FRANKLIN, Mass., March 16
/PRNewswire-FirstCall/ -- PLC Medical Systems, Inc. (AMEX:PLC), a
company focused on innovative cardiac and vascular medical
device-based technologies, announced the successful enrollment of
the first patients in its FDA-approved clinical trial designed to
evaluate the safety of its RenalGuard System(TM). Safety results
were favorable, and there were no adverse renal events related to
the device recorded. The RenalGuard System and RenalGuard
Therapy(TM) are intended to reduce the incidence of Contrast-
Induced Nephropathy (CIN) by managing real-time fluid balance and
diuresis in conjunction with interventional procedures where
contrast media are administered. The procedures, all done in
conjunction with a percutaneous coronary intervention (PCI)
employing multiple stents, were safely performed by Richard B.
Zelman, M.D., at Cape Cod Hospital in Hyannis, Massachusetts. "The
use of RenalGuard Therapy maintained a high level of urine output,
which is believed to reduce potential renal toxicity by protecting
the kidney during interventional cardiac procedures requiring
contrast media," said Dr. Zelman. "The system operated smoothly and
did not change the flow of the catheterization procedure. The
patients' procedures were completed successfully and the patients
experienced no adverse renal complications." "We are pleased by the
positive, promising experience of our first patients to utilize the
RenalGuard System and associated therapy," stated Mark R. Tauscher,
President, PLC Medical Systems, Inc. "This first step gives us
confidence that we will complete this pilot trial successfully."
Contrast-Induced Nephropathy Approximately seven million patients
worldwide undergo interventional therapeutic and diagnostic
procedures each year. Contrast-Induced Nephropathy (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, major in- hospital adverse
cardiac events, and risk of 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%. RenalGuard(TM)
RenalGuard(TM) is an investigational system and therapy that
targets patients with compromised renal function who may be at risk
for CIN. RenalGuard Therapy is based on existing pre-clinical study
data that support the theory that initiating and maintaining high
urine output allows the body to rapidly eliminate contrast,
reducing its toxic 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. 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 Report on Form 10-K for the year ended December
31, 2005, and our other SEC reports. 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
Medical Systems, Inc. CONTACT: Mary T. Conway, Conway
Communications, +1-617-244-9682, Web site: http://www.plcmed.com/
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