PLC Medical Systems Names Lead Investigators for Pivotal Trial to Evaluate RenalGuard System(TM) and RenalGuard Therapy(TM)
19 Dezembro 2007 - 11:00AM
PR Newswire (US)
Trial designed to evaluate effectiveness of RenalGuard(TM) in
preventing Contrast -Induced Nephropathy FRANKLIN, Mass., Dec. 19
/PRNewswire-FirstCall/ -- PLC Systems Inc. (AMEX:PLC), a company
focused on innovative cardiac and vascular medical device-based
technologies, announced today that it has named two lead
investigators for the upcoming pivotal trial of its RenalGuard
Therapy(TM). The lead investigators are Charles Davidson, MD,
Professor of Medicine, Northwestern University Medical School and
Richard J. Solomon, MD, Professor of Medicine, University of
Vermont College of Medicine. The trial is designed as a
multi-center, prospective, randomized controlled trial to evaluate
the effect of RenalGuard(TM) in the prevention of Contrast-Induced
Nephropathy (CIN) during cardiovascular and peripheral imaging
procedures performed in a catheterization lab. PLC intends to begin
enrollment in the RenalGuard Pivotal Trial in early 2008, following
receipt of the necessary approval from the U.S. Food & Drug
Administration. "Contrast-Induced Nephropathy is the third most
common cause of in- hospital acute renal failure," stated Dr.
Solomon. "The data on current prevention methods is largely
inconclusive. It is our hope that this study will help determine
the preventative benefits of RenalGuard Therapy in clinical use."
Dr. Davidson added, "CIN is a major issue for at-risk patients
undergoing imaging procedures and can result in longer hospital
stays and higher mortality rates. A cost-effective, easy-to-use
preventive measure could reduce costs and save lives." RenalGuard
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 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(TM) is
a fully-automated, real-time matched fluid replacement device
intended for interventional cardiology and radiology patients
undergoing imaging procedures using contrast media. PLC conducted a
pilot study to confirm the safety of RenalGuard. Based upon the
positive safety data collected in the pilot study and discussions
with FDA, PLC stopped enrolling new patients in the pilot study and
is preparing to submit a formal request to transition into a new
pivotal trial protocol. 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 conducted 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," "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,
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-Q for the quarter ended September 30, 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,
, for PLC Systems Inc. Web site: http://www.plcmed.com/
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