Navigation Links
Results From Pilot Trial of PLC's RenalGuard® Published in International Journal of Cardiology
Date:1/17/2012

MILFORD, Mass., Jan. 17, 2012 /PRNewswire/ -- PLC Systems Inc. (OTC: PLCSF), a company focused on innovative medical device technologies, today announced that an article summarizing the results from its U.S. pilot trial for RenalGuard® has been published online in the December 26, 2011 International Journal of Cardiology, a peer-reviewed journal affiliated with the International Society of Adult Congenital Heart Disease. The results from this trial, which was completed in 2007 and presented at the American College of Cardiology conference in March 2009, confirmed that RenalGuard System™ "is safe and dynamically balances volume hydration."   

The trial was conducted in four clinical sites in the U.S. in 2006 and 2007, with a total of 23 patients enrolled, and was designed to evaluate the safety of RenalGuard System and RenalGuard Therapy®, under an Investigational Device Exemption (IDE) approved by the U.S. Food and Drug Administration (FDA).  The results of this feasibility study illustrate that RenalGuard can safely help maintain high rates of urine output without significant hemodynamic or systemic adverse reactions.   

PLC's U.S. pivotal trial to study the efficacy of RenalGuard Therapy and RenalGuard System in the prevention of Contrast-Induced Nephropathy (CIN) is currently underway under the supervision of Principal Investigators Charles Davidson, MD, Professor of Medicine, Northwestern University Medical School, Richard J. Solomon, MD, Professor of Medicine, University of Vermont College of Medicine and Roxana Mehran, MD, Professor of Medicine at Mount Sinai School of Medicine.

The International Journal of Cardiology article can be accessed at the following link:  http://www.ncbi.nlm.nih.gov/pubmed/22204847 or by visiting PLC's website (www.plcmed.com). 

About RenalGuard

RenalGuard is based on data that shows that initiating and maintaining high urine output during imaging procedures allows the body to rapidly eliminate toxins in contrast media, reducing their harmful effects.  RenalGuard is a fully-automated, real-time matched fluid replacement device intended for interventional cardiology and radiology patients undergoing imaging procedures using contrast media. 

About PLC Systems

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 cardiac and vascular 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.

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 U.S. clinical trial for RenalGuard may not be completed in a timely fashion, if at all, or, if this clinical trial is completed, it may not produce clinically significant or meaningful results, the RenalGuard product may not be commercially accepted, operational changes, the need for additional financing, 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.

Contact:

Mary T. Conway

 

508-520-2545

 

mconway@plcmed.com


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

Related medicine technology :

1. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
2. Lexicon to Present Research Results at American Chemical Society Meeting Regarding Target of LX1031 Drug Candidate
3. Positive Kuvan(TM) Pivotal Phase 3 Trial Results Published in The Lancet
4. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
5. Tapestry Reports Second Quarter 2007 Results
6. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
7. Emisphere Technologies, Inc. Announces 2007 Second Quarter Financial Results
8. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
9. Genta Incorporated Announces Second Quarter 2007 Financial Results and Corporate Highlights
10. Vical Reports Second Quarter 2007 Financial Results, Allowance of Pandemic Influenza IND and Other Advances in Product Development Programs
11. MicroDose Announces Positive Results From the QDose Inhaled Insulin Glucose Clamp Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... June 23, 2016 Research and Markets ... Medical Market Analysis 2016 - Forecast to 2022" report ... The report contains up to date financial data derived from ... of major trends with potential impact on the market during ... market segmentation which comprises of sub markets, regional and country ...
(Date:6/23/2016)... INDIANAPOLIS , June 23, 2016 If ... Leaders Scholarship is any indication, the future is in ... at www.diabetesscholars.org by the Diabetes Scholars Foundation ... the way of academic and community service excellence. ... since 2012, and continues to advocate for people with ...
(Date:6/23/2016)... Research and Markets has announced the addition ... States, China, Japan, Brazil, United Kingdom, Germany, France, Italy, ... Surgical Procedure Volumes: Global ... surgical procedure volume data in a geographic context. The ... of growth drivers and inhibitors, including world population growth, ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... , ... First Choice Emergency Room , the largest network of independent ... Director of its new Mesquite-Samuell Farm facility. , “We are pleased to announce ... Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , ...
(Date:6/25/2016)... ... 2016 , ... Conventional wisdom preaches the benefits of moderation, whether it’s a ... the bar too high can result in disappointment, perhaps even self-loathing. However, those who ... , Research from PsychTests.com reveals that behind the tendency to set ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was ... his family verbally and physically. , “When something upset him, he couldn’t control his emotions,” ... He would throw rocks at my other children and say he was going to kill ...
(Date:6/24/2016)... ... 24, 2016 , ... Comfort Keepers® of San Diego, CA is excited to ... Recovery® program to drive cancer patients to and from their cancer treatments. Comfort ... quality of life and ongoing independence. Getting to and from medical treatments is ...
(Date:6/24/2016)... New York, NY (PRWEB) , ... June 24, ... ... lifestyle publication Haute Living, is proud to recognize Dr. Barry M. Weintraub as ... believes that “the most beautiful women in the world, and the most handsome ...
Breaking Medicine News(10 mins):