PLC Presents Two Abstracts at CRT 2007
2007年3月7日 - 10:00PM
PRニュース・ワイアー (英語)
High Volume Diuresis Combined With Matched Maintenance of
Intravascular Volume May Prevent Contrast-Induced Nephropathy
FRANKLIN, Mass., March 7 /PRNewswire-FirstCall/ -- High volume
diuresis combined with matched maintenance of intravascular volume
may reduce the incidence of contrast-induced nephropathy in
post-transplant patients with moderate to severe renal impairment,
according to a study to be presented at the CRT 2007 conference,
March 7-9, 2007 in Washington, DC. The study was conducted at
Newark-Beth Israel Hospital, Newark, NJ, and involved 10 patients.
The patients were post one year heart transplantation recipients
with baseline creatinine clearances between 20 and 60 ml/min. Each
received contrast doses ranging from 50 to 200 ml of Visipaque, and
standard doses of Mucomyst (acetylcysteine) and sodium bicarbonate.
A nurse monitored the urine output and matched the infusion rate
for intravenous fluid replacement in order to maintain the
patient's intravascular volume. The urine volume for all patients
averaged about 1000 ml/hour during the delivery of therapy. None of
the patients experienced any adverse changes in oxygen saturation
or hemodynamics nor complained of shortness of breath. Some
patients had a reduction in serum potassium and magnesium that
required oral replacement. There was essentially no change in serum
creatinine from baseline in 9 out of the 10 patients
post-procedure, indicating no occurrence of Contrast- Induced
Nephropathy or CIN. Despite high urine outputs, no serious or
unexpected adverse events were observed. No patient had any
evidence of fluid overload and only one patient experience
orthostatic hypotension that responded to oral fluids. "The data
suggests that high urine output with matched replacement hydration
to maintain intravascular volume may reduce the incidence of CIN in
heart transplant patients," stated David A. Baran, M.D., Director
of Heart Failure and Transplant Research, Newark Beth Israel
Medical Center, Newark, NJ. "These results suggest that this method
should be further evaluated as a therapy for CIN." A second study
conducted with dogs also suggested that the incidence of CIN is
reduced by inducing high volume diuresis and matched replacement of
intravascular volume. This study will also be presented at CRT
2007. Both studies were supported by PLC Systems, Inc. (AMEX:PLC),
which has been developing its RenalGuard Therapy(TM) for the
prevention of CIN. PLC believes that the studies may provide the
basis for proof of concept for RenalGuard, which 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. This therapy is intended to be used to reduce the
toxic effects that contrast media can have on the kidneys.
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 requiring
interventional procedures that use radiographic contrast media. CIN
is the third most common cause of in-hospital acute renal failure,
and is associated with significant in-hospital mortality rates,
increased long-term mortality, increased major in-hospital adverse
cardiac events, and increased risk of renal dialysis therapy, as
well as 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 such
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 and
industry 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. In a move to broaden its market, the
company is initiating clinical studies for RenalGuard, its matched
fluid replacement device intended for interventional cardiology and
radiology patients undergoing diagnostic and therapeutic imaging
catheterization 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 that the data cited above
may not be supported by future clinical trials, 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 Systems, Inc. CONTACT:
Mary T. Conway, Conway Communications, +1-617-244-9682 or , for PLC
Systems Inc. Web site: http://www.plcmed.com/
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