FRANKLIN, Mass., May 18, 2011 /PRNewswire/ — PLC Systems Inc.
(OTCBB: PLCSF), a company focused on innovative medical device
technologies, today announced that it has named Susan Papalia, RN,
BSN, Vice President of Clinical Affairs. In her new role, she
will be responsible for overseeing and leading the U.S. clinical
study of the company’s innovative product, RenalGuard®.
RenalGuard has already obtained the CE Mark in the European Union,
and PLC plans to commence the pivotal trial in the U.S. to seek
approval for sales and marketing from the U.S. Food & Drug
Administration.
Said Mark R. Tauscher, President and Chief Executive Officer,
“Susan brings to PLC more than 20 years of experience in clinical
research and regulatory approvals related to the launch of new
medical devices in the U.S. and international markets. With
her expertise and our innovative technology, we are looking forward
to the first subject enrollments in the U.S. pivotal trial for
RenalGuard. We are confident that the results will confirm
the effectiveness of RenalGuard and the associated RenalGuard
Therapy® in reducing the incidence of Contrast-Induced
Nephropathy (CIN) in at-risk patients, as already demonstrated in
the results from the investigator-sponsored REMEDIAL II and MYTHOS
clinical trials in Italy.”
Ms. Papalia joins PLC Medical Systems from Correx, Inc., where
she was VP of Clinical Affairs and played a key role in the launch
of the Correx Aortic Valve Bypass (AVB) kit in the EU and Canada.
Prior to that, she held a series of senior clinical affairs
positions at both Boston Scientific Corporation and Mitralign, Inc.
and clinical research positions in cardiology at the New England
Medical Center and St. Elizabeth’s Hospital in Boston, MA. Ms.
Papalia earned her degrees at SUNY Plattsburgh and her CCRA
certification from the Association of Clinical Research
Professionals. She is an active member of the Massachusetts Medical
Res
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