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:6/23/2016)...  In a startling report released today, National Safety Council ... a comprehensive, proven plan to eliminate prescription opioid overdoses. ... states are tackling the worst drug crisis in recorded U.S. history, ... Kentucky , New Mexico , ... the 28 failing states, three – Michigan , ...
(Date:6/23/2016)... , June 23, 2016 Research and ... News Issue 52" report to their offering. ... influenza treatment creates a favourable commercial environment for MedImmune to ... patient base that will serve to drive considerable growth for ... would serve to cap sales considerably, but development is still ...
(Date:6/23/2016)... and BOGOTA, Colombia , June 23, 2016  Astellas today announced the establishment of ... Farma Brasil as the company,s second affiliate in Latin America . ... ... Manager of Astellas Farma Colombia ... ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... 2016 , ... PawPaws brand pet supplements owned by Whole Health ... the health of felines. The formula is all-natural and is made from Chinese herbs ... Cat Kidney Support Supplement Soft Chews are Astragalus Root Extract and Rehmannia ...
(Date:6/25/2016)... ... ... The temporary closing of Bruton Memorial Library on June 21 due to a possible lice ... overlooked aspect of head lice: the parasite’s ability to live away from a human host, ... a necessary one in the event that lice have simply gotten out of control. , ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, Secretary of ... award to iHire in recognition of their exemplary accomplishments in worksite health promotion. , ... Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was ...
(Date:6/24/2016)... PASADENA, CA (PRWEB) , ... June 24, 2016 , ... Marcy was in a crisis. ... he would lash out at his family verbally and physically. , “When something upset him, ... table, he would use it. He would throw rocks at my other children and say ...
(Date:6/24/2016)... ... ... of Topricin and MyPainAway Pain Relief Products, join The ‘Business for a Fair Minimum Wage’ ... 2020 and then adjusting it yearly to increase at the same rate as the median ... floor does not erode again, and make future increases more predictable. , The company is ...
Breaking Medicine News(10 mins):