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