FRANKLIN, Mass., June 2, 2011 /PRNewswire/ — PLC Systems Inc.
(OTCBB: PLCSF), a company focused on innovative medical device
technologies, today announced that it is preparing to commence the
pivotal trial in the U.S. for the company’s innovative product,
RenalGuard®, to seek approval for sales and marketing in the
U.S. from the U.S. Food & Drug Administration. RenalGuard
has already obtained the CE Mark in the European Union.
As part of this effort, the company has added Roxana Mehran, MD,
Professor of Medicine at Mount Sinai School of Medicine, as a
Principal Investigator for the trial, joining Charles Davidson, MD,
Professor of Medicine, Northwestern University Medical School and
Richard J. Solomon, MD, Professor of Medicine, University of
Vermont College of Medicine. Dr. Mehran is well known
worldwide for her work and leadership in the field of CIN
prevention. She is internationally recognized for her work as a
clinical trial specialist with complex data analyses and outcomes
research within the field of interventional cardiology. She is
recognized for her experience and expertise in working with
regulatory agencies to conduct clinical trials.
Said Mark Tauscher, President and CEO, “We look forward to the
commencement of our U.S. pivotal trial for RenalGuard. This
trial will be conducted to test the effectiveness of RenalGuard and
the associated RenalGuard Therapy® in reducing the incidence of
Contrast-Induced Nephropathy (CIN) in at-risk patients. The
Italian investigator-sponsored REMEDIAL II and MYTHOS clinical
trial results have demonstrated meaningful reduction of CIN in
at-risk patients using RenalGuard. Dr. Mehran is a noted
expert in the field of CIN prevention, and her clinical trials
expertise will prove to be extremely valuable moving forward. We
are working diligently to lay the foundation for the first patient
enrollments for the U.S. pivotal trial for RenalGuard.”
RenalGua
‘/>”/>
