Navigation Links
REMEDIAL II Trial of PLC's RenalGuard® Article Published in Circulation
Date:8/18/2011

MILFORD, Mass., Aug. 18, 2011 /PRNewswire/ -- PLC Systems Inc. (OTCBB: PLCSF), a company focused on innovative medical device technologies, today announced that final results from the REMEDIAL II investigator-sponsored clinical trial of RenalGuard® in Italy have been published on-line in Circulation, a peer-reviewed journal of the American Heart Association with a distribution of 23,900 worldwide, and will appear in the September 2011 issue of the publication.  The results from this trial showed that RenalGuard is superior to the current standard of care at preventing Contrast-Induced Nephropathy (CIN) and in-hospital dialysis in high-risk patients undergoing certain imaging procedures.

In this trial, the investigators discovered that patients treated with RenalGuard and N-acetylcysteine (NAC) developed CIN, a serious and potentially fatal condition, at a much lower rate than patients in the control group who were treated with an infusion of sodium bicarbonate and NAC. Sodium bicarbonate plus NAC remains the current standard of care for the prevention of CIN in many healthcare institutions worldwide. The results provided strong scientific data that RenalGuard Therapy® is superior to sodium bicarbonate and N-acetylcysteine in preventing contrast-induced acute kidney injury (CI-AKI) in high-risk patients.

Mark R. Tauscher, President and Chief Executive Officer of PLC Systems, said, "The positive results of the REMEDIAL II clinical trial demonstrate with scientifically significant findings that RenalGuard is a superior approach to reducing the incidence of CIN in high-risk patients. This is another important proof point for RenalGuard and for PLC, and we're delighted that these results have been favorably evaluated by Circulation's advisory board and are now being shared with practitioners and potential partners from around the world. We believe that greater awareness of such positive scientific findings will help us attract more interest from distributors, partners and customers for RenalGuard in the markets were it is available. I would particularly like to thank Dr. Carlo Briguori, MD, PhD, Chief, Laboratory of Interventional Cardiology, Clinica Mediterranea, Naples, Italy, for his leadership in the field of CIN prevention and forutilizing PLC's RenalGuard in this trial."

Dr. Briguori reported on data from 294 patients with chronic kidney disease (CKD) who underwent elective catheterization procedures for diagnostic imaging. The primary end point for the study used a definition of CIN as a rise in serum creatinine (SCr) of 0.3mg/dl over the patient's baseline reading. The RenalGuard-treated group had a CIN incidence rate 46% lower than the control group using this definition of CIN. In secondary endpoints, he also reported a 60% reduction in CIN in the RenalGuard-treated group compared to the control group when defining CIN as a 0.5mg/dl absolute rise in SCr and an 80% reduction of CIN in the RenalGuard-treated group over the control group when defining CIN as a 25% rise over baseline SCr.

The development of CIN has been found to lead to a range of serious and potentially deadly outcomes in patients who already have compromised kidney function. Notably the trial also found that RenalGuard Therapy significantly reduced the need for in-hospital dialysis in high risk patients. In the control group, seven or 4.8% of these patients required some level of dialysis. Only 1 patient (0.7%), or 85% fewer, in the RenalGuard-treated group required dialysis.

The Circulation article can be accessed at the following link: http://circ.ahajournals.org/content/early/2011/08/13/CIRCULATIONAHA.111.030759.abstractor by visiting PLC's website (www.plcmed.com).

About PLC Systems Inc.

PLC Systems Inc., headquartered in Milford, Mass., is a medical device company focused on innovative technologies for the cardiac and vascular markets. PLC's newest product, RenalGuard, has been developed to help prevent the onset of Contrast-Induced Nephropathy (CIN) in at-risk patients undergoing certain imaging procedures. The Product is CE-marked and is being marketed in Europe and selected countries around the world. Two investigator-sponsored European studies have demonstrated RenalGuard's effectiveness at preventing CIN. RenalGuard is being studied in a pivotal trial in the U.S., as required for approval by FDA, and has not been approved for patient use in the United States.

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 or that such approvals may be withdrawn, the current clinical trials in Italy and the planned future U.S. clinical trial for RenalGuard may not be completed in a timely fashion, if at all, or, if these clinical trials are completed, they may not produce clinically significant or meaningful results, 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 the "Forward Looking Statements" section of our Annual Report on Form 10-K for the year ended December 31, 2010, a copy of which is on file with the SEC.

PLC Systems, PLC Medical Systems, PLC, RenalGuard and RenalGuard Therapy are trademarks of PLC Systems Inc.

For information contact:
Mary T. Conway
508-520-2545
marytconway@comcast.net


'/>"/>
SOURCE PLC Systems Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. REMEDIAL II Results on PLC Systems RenalGuard® to be Presented at ACC 2011s Late Breaking Clinical Trial Session
2. REMEDIAL II Trial of PLCs RenalGuard® Demonstrates Greater Efficacy than Current Standard of Care
3. Progen Engages Leading CRO to Assist with Phase 3 Trial of PI-88
4. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
5. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
6. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
7. Millennium Initiates Clinical Trial to EVOLVE the Treatment of Patients with Newly Diagnosed Multiple Myeloma
8. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
9. Positive Kuvan(TM) Pivotal Phase 3 Trial Results Published in The Lancet
10. Clinical Trial Effectiveness: How Pharmas & Biotechs Save Cost with Savvy Investigator Management
11. TaiGen Biotechnology Successfully Completes Patient Recruitment for Phase II Trial of Nemonoxacin for Treatment of Adult Community Acquired Pneumonia (CAP)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... May 25,2016 FDA 510(k) ... Cellvizio platform for urological and surgical applications ... inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy ... in the US with the 12 th ... Administration (FDA). This new FDA clearance covers Confocal ...
(Date:5/25/2016)...  Zymo Research Corp. announced today the final ... that help researchers obtain the most accurate and ... rapid growth of the study of microbiomes has ... methods to improve the reproducibility and quality of ... every step of the measurement process including collection ...
(Date:5/25/2016)... May 25, 2016  Granger Diagnostics today announced immediate ... wounds and infections. This test ensures discovery of ... viruses. The test requires only a simple swab of ... David G. Bostwick , MD, Chief Medical ... wound healing: "We are excited to make available, ...
Breaking Medicine Technology:
(Date:5/27/2016)... ... 27, 2016 , ... An educational campaign aimed at everyone ... courtesy of awareness-driven celebrities and thought leaders. It also provides insight to the ... leaders such as Bioness. , As patients feel increasingly concerned about the ...
(Date:5/27/2016)... PALMYRA, Wis. (PRWEB) , ... May 27, 2016 ... ... over $90,000 in scholarships to students studying complementary medicine. Allison Outerbridge is this ... She accepted her award on May 18 at the university’s Student Leadership Awards ...
(Date:5/26/2016)... ... May 26, 2016 , ... ... thousands of defective respirators, according to court documents and SEC filings. A ... and Becky Tyler v. American Optical Corporation, Case No. BC588866, Los Angeles County, ...
(Date:5/26/2016)... ... May 26, 2016 , ... The Woodlands at John Knox ... new model of care for living and healing, celebrated its grand opening, today. The ... a Real Home provided by Empowered Staff. , “This is an incredibly fulfilling time ...
(Date:5/26/2016)... ... May 26, 2016 , ... ... for the Foundation Fighting Blindness, Long Island Chapter on June 4, 2016, 1:30-3:30 ... , Dr. Maisel, founder of Retina Group of New York , is ...
Breaking Medicine News(10 mins):