PLC Systems Announces Approval of First European Study to Evaluate RenalGuard(TM)
2008年5月30日 - 10:01PM
PRニュース・ワイアー (英語)
Trial designed to evaluate effectiveness of device in preventing
Contrast-Induced Nephropathy FRANKLIN, Mass., May 30
/PRNewswire-FirstCall/ -- PLC Systems Inc. (AMEX:PLC), a company
focused on innovative cardiac and vascular medical device-based
technologies, announced today that the ethics committee of the
Centro Cardiologico Monzino (CCM-University of Milan), Milan, Italy
has approved the planned randomized clinical trial to evaluate the
use of RenalGuard(TM) in the prevention of Contrast-Induced
Nephropathy (CIN) in high-risk patients undergoing catheterization
procedures at its institution. The investigators for the trial are
Dr. Antonio L. Bartorelli, Director, Interventional Cardiology,
CCM, and Professor of Cardiology, University of Milan, and Dr.
Giancarlo Marenzi, Chief, Intensive Cardiac Care Unit, CCM, who are
two of the world's leading experts in the prevention of CIN. PLC's
President and Chief Executive Officer, Mark R. Tauscher, said, "We
are very pleased that this study has received approval from CCM's
ethics committee. We anticipate that this study will greatly
increase the visibility of our RenalGuard System in Europe, and
that the data gathered from the study will enable us to seek
expanded claims in order to market RenalGuard as a CIN prevention
device throughout the European Union." The trial is designed as a
prospective, open, randomized trial to provide an assessment of the
potential benefits of induced diuresis with matched hydration
therapy, compared to standard overnight hydration, in the
prevention of CIN in patients undergoing cardiac catheterization
procedures and percutaneous coronary interventions with baseline
impairment in renal function. The CIN-prevention therapy of induced
diuresis and matched hydration therapy will be provided using
RenalGuard. "Contrast-Induced Nephropathy is a risky complication
resulting from the use of contrast media for coronary and
peripheral vascular diagnostic and interventional procedures in
at-risk patients," stated Dr. Bartorelli. "Previous studies at our
institution have demonstrated the benefit of hemofiltration in
preventing CIN in patients with chronic renal failure. Our
objective with this study is to assess the potential benefits of
induced diuresis with matched hydration therapy compared to
standard overnight hydration for the prevention of CIN." Dr.
Marenzi added, "CIN is a major life-threatening issue for at-risk
patients undergoing imaging procedures since it can result in
longer hospital stays and higher mortality rates. A cost-effective,
easy-to-use preventive measure could save lives and reduce costs."
RenalGuard is based on existing 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 effect. RenalGuard is a
fully-automated, real-time matched fluid replacement device
intended for interventional cardiology and radiology patients
undergoing imaging procedures using contrast media. In the U.S.,
PLC recently completed a pilot safety study 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 has received FDA conditional approval to commence a
U.S. pivotal trial to study the effectiveness of its RenalGuard in
the prevention of CIN. 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. PLC's
newest product program, RenalGuard (an investigational device in
the U.S.), targets a costly and potentially deadly medical
condition known as Contrast-Induced Nephropathy (CIN). Patients
undergoing image-guided procedures, such as those performed when
placing drug-eluting stents, can develop CIN because of the
potentially toxic effects that contrast media used during these
procedures can have on the kidneys. RenalGuard 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 company received its CE Mark Certificate for
RenalGuard, and has received approval from the U.S. Food and Drug
Administration to commence a U.S. pivotal trial to study the safety
and effectiveness of RenalGuard in the prevention of CIN.
Headquartered in Franklin, Massachusetts, 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. 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 the CCM
and other clinical trials for the RenalGuard product may not yield
anticipated results, we may not receive necessary regulatory
approvals to market our RenalGuard product, 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 Annual Report on Form 10-K
for the year ended December 31, 2007, and our other SEC reports.
PLC Systems, PLC Medical Systems, PLC and CO2 Heart Laser, and
RenalGuard 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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