Navigation Links
First Patient Treated in PLC Systems' RenalGuard® U.S. Pivotal Trial
Date:1/23/2012

opments since 2008, we made slight modifications to our original trial protocol that we believe will make it more robust. This is a very important step on our path forward to seeking FDA approval to market RenalGuard in the U.S."

PLC's U.S. pivotal study is 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 Dr. Mehran. It is designed as an adaptive, randomized controlled trial at up to 30 sites in the U.S. Enrollment in the trial will include at least 326 patients and potentially up to 652 patients, depending upon the outcome of a sample size re-estimation after 163 patients. The sample size re-estimation, often used in adaptive trials, enables investigators to ensure that the trial is sufficiently powered so that the final results are statistically meaningful.

PLC's U.S. study builds upon two clinical trials by independent clinical investigators in Europe, both of which showed significant reductions in incident rates of CIN in at-risk patients through the use of RenalGuard compared to the current standard of care.

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 purpo
'/>"/>

SOURCE PLC Systems Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
2. Sixty-One Percent of Newly Diagnosed Parkinsons Disease Patients Do Not Receive Any Drug Treatment in the First Year of Diagnosis
3. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
4. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
5. Video: Landmark Study in The Lancet: Patients Treated With Betaseron(R) After First MS Attack Experienced Significant Delay in MS Progression
6. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
7. Tainted Chinese Food Ingredients First Discovered in 2005
8. First Patient Enrolled in Europe in Ovature Phase III Ovarian Cancer Trial
9. Protalix BioTherapeutics Treats First Patient in Phase III Clinical Trial of prGCD
10. Human Genome Sciences Completes Enrollment of First Phase 3 Albuferon(R) Trial Ahead of Schedule
11. Opko Health Doses First Patient in Phase 3 COBALT Trial of Bevasiranib for the Treatment of AMD
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/21/2014)... 2014 /CNW/ - Eisai Limited is pleased to support the ... comic book available in Canada . The ... to educate children and their parents about epilepsy, the most ... more than 300,000 Canadians. Eisai is guided by a corporate ... which the patient is central – there was a need ...
(Date:8/21/2014)... 21, 2014 /PRNewswire-iReach/ -- Inc. magazine ... the third straight year, No. 349 in Health ... ranking of the nation,s fastest-growing private companies. The ... most important segment of the economy—America,s independent entrepreneurs. ... Pizza, LinkedIn, Zillow, and many other well-known names ...
(Date:8/21/2014)... , Aug. 21, 2014  Seventy-one percent of Americans believe ... is a serious public health and safety issue in ... a survey released today by Repass & Partners, a ... "Americans understand the severity of the prescription medication abuse ... with this very serious health situation facing our country," ...
Breaking Medicine Technology:Eisai Pleased to Support Canadian Epilepsy Alliance Comic Book that Teaches Children About Epilepsy 2Carolina's HME Named for Third Straight Year to Inc. Magazine's List of America's Fastest-Growing Private Companies--the Inc. 5000 2Carolina's HME Named for Third Straight Year to Inc. Magazine's List of America's Fastest-Growing Private Companies--the Inc. 5000 3Consumers Desperate For Measures To Curb Prescription Drug Abuse 2Consumers Desperate For Measures To Curb Prescription Drug Abuse 3
... became the third hospital in the United States to perform ... Resonance Imaging scanner, or iMRI. "This is a ... M.D., Director of Movement Disorder and Behavioral Neurosurgery at Henry ... mapping is still the standard of care for DBS, some ...
... 23, 2011 BASIS Science, Inc., creators of the Basis™ ... that includes medical, social and gaming luminaries including Kevin Colleran, ... announced it has hired Chris Verplaetse to join the company,s ... Due to be launched later this year, the Basis ...
Cached Medicine Technology:DBS Operation for Parkinson's Disease Performed Inside iMRI 2Basis Announces Advisory Board Members from Medicine, Gaming and Social Networking 2Basis Announces Advisory Board Members from Medicine, Gaming and Social Networking 3
(Date:8/21/2014)... 22, 2014 Recently, Skmen.com, a distinguished garment ... of girls’ casual dresses . From today until ... to 30 percent off) when they are shopping at the ... casual outfits are according to the newest quality standards; they ... the charming casual dresses, worldwide ladies can also access the ...
(Date:8/21/2014)... Recently, iFitDress.com, a famous online supplier of wedding dresses and ... new range of plus size evening dresses for 2014 ... all these fashionable gowns are available at discounted rates, up ... “We are very proud to unveil the new plus size ... variety of fashionable outfits at affordable rates. They are all ...
(Date:8/21/2014)... 2014 AVEC Health Solutions, LLC, ... addition of Kerry Gillespie as Chief Executive Officer. ... experience, Gillespie brings an extremely robust background to ... positions with prominent industry leading organizations across the ... of Triad Isotopes, Inc. a private nuclear pharmaceutical ...
(Date:8/21/2014)... (PRWEB) August 21, 2014 The costs paid ... continue to rise, according to insurer data. The Quotes Pros ... in real time using its tools at http://quotespros.com . ... the company homepage connects with providers offering multiple coverage packages ... are promoted to the public are now easier to compare ...
(Date:8/21/2014)... Top10BestSEOHosting.com has recently compared many ... ( http://www.top10bestseohosting.com/go/iPage/ ) is one of the best ... The manager of Top10BestSEOHosting.com states, “It is hard ... these companies have outperformed their competitors on hosting ... can get the best web hosting at affordable ...
Breaking Medicine News(10 mins):Health News:Charming Girls’ Casual Dresses Now Released by Distinguished Garment Company Skmen.com 2Health News:iFitDress.com: Cheap Plus Size Evening Dresses for 2014 Now Available 2Health News:Kerry Gillespie Appointed as Chief Executive Officer of AVEC Health Solutions 2Health News:Dental Insurance Now Quoted for Families Online at Insurer Portal 2Health News:iPage Reviews Unveiled Online At Top10BestSEOHosting.com 2
... the translation of basic discoveries about HIV into advances ... Allergy and Infectious Diseases (NIAID), part of the National ... Discovery Branch within the Vaccine Research Program in the ... scientific consensus that designing a safe and effective vaccine ...
... is a national concern that led the U.S. surgeon ... and Reduce Underage Drinking" ( http://www.surgeongeneral.gov/topics/underagedrinking/ ) last year. ... researcher assesses the effectiveness of underage drinking prevention programs ... key goals outlined by the surgeon general. , Lead ...
... certifies that Mannatech,s manufacturer meets Good Manufacturing ... ... Texas, June 25 Mannatech,Incorporated (Nasdaq: MTEX ), a ... today announced that the purity of,Mannatech,s Ambrotose and Advanced Ambrotose ...
... June 25 Hologic, Inc.,(Nasdaq: HOLX ) today ... the waiting period under the Hart-Scott-Rodino,Antitrust Improvements Act of ... in connection with Hologic,s previously announced tender offer for,all ... Third Wave,Technologies, Inc. (Nasdaq: TWTI ). The early ...
... Summit and recognizes industry,s top ... ... global,supply chain management company, was voted "Best 3PL for Pharma, Chemical,and ... as part of,eyefortransport,s 2008 Best North American 3PL Awards. eyefortransport is ...
... , ... Alexandria, Va. (PRWEB) June 24, 2008 -– Today, the National ... H.R.6331, the Medicare Improvements for Patients and, , , ,Providers Act of ... the patients they serve. , , ,In a letter to House Ways ...
Cached Medicine News:Health News:NIAID creates HIV vaccine discovery branch 2Health News:Pediatrics review of underage drinking prevention programs led by Iowa State researcher 2Health News:Pediatrics review of underage drinking prevention programs led by Iowa State researcher 3Health News:NSF International Certifies Purity of Four Mannatech Products 2Health News:NSF International Certifies Purity of Four Mannatech Products 3Health News:NSF International Certifies Purity of Four Mannatech Products 4Health News:Hologic, Inc. Announces Grant of Early Termination of Antitrust Waiting Period for Third Wave Technologies, Inc. Tender Offer 2Health News:CEVA Logistics Awarded Best 3PL Provider for Pharmaceutical, Chemical, HazMat and Fresh Food Supply Chains 2Health News:CEVA Logistics Awarded Best 3PL Provider for Pharmaceutical, Chemical, HazMat and Fresh Food Supply Chains 3Health News:NACDS Praises House Legislation to Delay Medicaid Cuts, Aid Pharmacies in Treating Patients 2
... stereomicroscopes are of the single-objective ... mature modular design they optimally ... hand. This is an advantage ... applications will appreciate, not least ...
6.3X Zoom Ratio - Boasting magnifications from 0.8X to 5X, the twin zooming objective optical system developed exclusively by Nikon provides a zoom ratio of 6.3:1. Clickstops at 1X intervals allow ob...
10:1 Zoom Ratio - The parallel optical system of the SMZ-1000 has a 10:1 zoom with clickstops at 1X intervals. It features a zoom range of 0.8X to 8.0X and total magnification (depending on eyepieces...
Fixed Versatility - With a diverse selection of body tubes, stands, lighting techniques and Nikon's world-renowned optics, this modular microscope can be configured to fit nearly any application....
Medicine Products: