Navigation Links
PLC Systems Files IDE Supplement to Begin Pivotal Study of RenalGuard(TM) and Provides Update on Planned Development Timeline
Date:2/15/2008

FRANKLIN, Mass., Feb. 15 /PRNewswire-FirstCall/ -- PLC Systems Inc. (Amex: PLC) announced today that it has submitted an Investigational Device Exemption (IDE) supplement with the U.S. Food & Drug Administration (FDA) for its RenalGuard Therapy(TM) and RenalGuard System(TM). This supplement seeks approval to move to a pivotal trial to study the effectiveness of the Company's RenalGuard Therapy and RenalGuard System in the prevention of Contrast-Induced Nephropathy.

According to the current timetable, PLC expects to commence the pivotal trial after receipt of FDA approval. Contrast-Induced Nephropathy, or CIN, is a major and growing problem due to the increasing number of older patients, diabetics and patients with pre-existing renal impairment -- all of whose conditions make them at risk for CIN when they require interventional procedures that use radiographic contrast media. This study is designed as an adaptive, randomized control trial, with potentially up to 30 sites in the U.S. Enrollment in the trial is expected to last through 2009, and to include at least 250 patients. PLC is continuing discussions with FDA on metrics and endpoints to be used in the study, in addition to sample size and other aspects of the study design, which is currently expected to cost approximately $3 million.

This trial design builds upon the successful completion of the company's pilot trial in December, a study that was designed to preliminarily evaluate safety associated with Renal Guard Therapy and RenalGuard System. A total of 23 patients were enrolled in the study.

Mark R. Tauscher, President and Chief Executive Officer of PLC, said, "We are very pleased with the continued progress on our RenalGuard studies. Submitting the IDE for t
'/>"/>

SOURCE PLC Systems Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine news :

1. New study shows extent of harmful human influences on global ecosystems
2. Microsoft Announces the Amalga Family of Health Enterprise Systems
3. Thomson Healthcares Clinical Xpert Navigator Tops KLAS Annual Performance Ranking in Mobile Data Systems for Sixth Consecutive Year
4. Harman/Becker Automotive Systems Completes Initial Deployments of Visiprise Integrated Manufacturing Execution
5. Merit Medical Systems Announces Earnings Release Date/Time and Conference Call Information for the Year Ended December 31, 2007
6. Microsoft Dynamics CRM 4.0 Users now can include Telephony and Call Recording features by adding ConversationPRO(TM) from VoiceGate, a Division of IgeaCare Systems Inc.
7. Keystone Human Services Acquires Impact Systems, Inc.
8. IDC Digital radiography systems Ranked #1 for third consecutive quarter
9. OxySure(R) Systems, Inc. Named to 2008 Worlds Best Technologies (WBT) List For its Unique, Safe and Easy to Use Portable Emergency Oxygen Generator, Which Provides Medical Oxygen Without the Need for Compressed Tanks
10. Cardicas C-Port Anastomosis Systems for Coronary Artery Bypass Graft Procedures to be Used to Train Cardiothoracic Surgeons at Society of Thoracic Surgeons (STS) University
11. Sonian Introduces the Most Affordable, Reliable and Scaleable Email Archiving Solution for All Messaging Systems
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/22/2014)... UK (PRWEB) September 22, 2014 The ... in the recent years. The statistically important data received ... safety of cancer vaccines. The primary challenge to the ... information about the exact mechanism of how a human’s ... to various results in different individuals owing to known ...
(Date:9/22/2014)... New York, New York (PRWEB) September 22, 2014 ... risks associated with the use of power morcellators ... Liebhard LLP notes a new report detailing the ... despite warnings from federal regulators that specifically discouraged ... these physicians believe that the potential cancer risks ...
(Date:9/22/2014)... 2014 (HealthDay News) -- Two new prescription devices approved ... provide some relief for people with migraine headaches who ... study. One device -- the Cefaly -- is ... the Cerena -- is meant to be used when ... "Patients have been looking for alternative migraine treatments. ...
(Date:9/22/2014)... CareFlight Air & Mobile Services ... a new AS365 N3+ Dauphin, the latest version of ... which is based at Miami Valley Hospital ... air medical transport helicopters. , “We have a lot ... Health Vice President, Emergency, Trauma, and CareFlight. “We’ve been ...
(Date:9/22/2014)... In a continued effort to support the ... launching an awareness campaign inspired by the ice bucket ... to raise awareness and funds for the cause. , ... the air and trying to catch it while blindfolded. ... nominee does not complete the challenge within 24 hours ...
Breaking Medicine News(10 mins):Health News:World Cancer Vaccines Market Landscape Examined by Kuick Research in New Study Published at MarketPublishers.com 2Health News:World Cancer Vaccines Market Landscape Examined by Kuick Research in New Study Published at MarketPublishers.com 3Health News:World Cancer Vaccines Market Landscape Examined by Kuick Research in New Study Published at MarketPublishers.com 4Health News:Power Morcellator News: Bernstein Liebhard LLP Notes New Report Detailing Continued Use of Uterine Morcellation Despite FDA Warning 2Health News:Power Morcellator News: Bernstein Liebhard LLP Notes New Report Detailing Continued Use of Uterine Morcellation Despite FDA Warning 3Health News:Power Morcellator News: Bernstein Liebhard LLP Notes New Report Detailing Continued Use of Uterine Morcellation Despite FDA Warning 4Health News:Noninvasive Devices May Help Migraines, FDA Says 2Health News:Miami Valley Hospital CareFlight begins Service with AS365 N3+ 2Health News:Miami Valley Hospital CareFlight begins Service with AS365 N3+ 3Health News:Blind Egg Challenge Raises Awareness for Foundation Fighting Blindness 2
... SETO Holdings, Inc. (Pink Sheets: SETO) announced that it signed ... (1) to issue shares of its Common Stock to acquire ... ("AHC"), a Maryland corporation which provides hearing services and retails ... Virginia, and (2) to sell all of SETO,s current businesses, ...
... how that happens may lead to ways around it, ... Temozolomide, a standard treatment for brain cancer, may boost ... more likely, a new study suggests. , The research ... City, have identified cells in brain tumors called gliomas ...
... Company Records 172% Year over Year Revenue Growth and ... Insulet,s International ExpansionBrian Roberts Appointed CFOBEDFORD, Mass., March 5 ... leader in tubing-free insulin pump technology with its OmniPod(R) ... fourth quarter and full year ended December 31, 2008. ...
... SEATTLE, March 5 Trubion Pharmaceuticals Inc. (Nasdaq: ... issue earnings results for the fourth quarter and year ... on March 12, 2009. The company,s earnings conference call ... Pacific Time, 5 p.m. Eastern Time. Both live events ...
... editors of the Harvard Health Letter , in consultation with the ... health care spending, saving society--and perhaps yourself--some money , ... Boston, MA ... will falter unless health care spending is brought under control. Moreover, even ...
... OpportunitiesHARRISBURG, Pa., March 5 Insurance Commissioner ... off from a job that offered health insurance to ... them with relief on premiums and that now is ... want to let Pennsylvanians know that additional help in ...
Cached Medicine News:Health News:SETO Holdings, Inc. Signs Letter of Intent to Dispose of all its Existing Businesses and Acquire Advanced Hearing Centers, Inc.; New Management to be Installed. 2Health News:Brain Tumor Drug May Help Spur Cancer's Return 2Health News:Brain Tumor Drug May Help Spur Cancer's Return 3Health News:Insulet Reports Fourth Quarter and Year End 2008 Results 2Health News:Insulet Reports Fourth Quarter and Year End 2008 Results 3Health News:Insulet Reports Fourth Quarter and Year End 2008 Results 4Health News:Insulet Reports Fourth Quarter and Year End 2008 Results 5Health News:Insulet Reports Fourth Quarter and Year End 2008 Results 6Health News:Insulet Reports Fourth Quarter and Year End 2008 Results 7Health News:Insulet Reports Fourth Quarter and Year End 2008 Results 8Health News:Trubion Announces Dates for Fourth-Quarter and Year-Ended 2008 Earnings Conference Call 2Health News:Runaway Health Care Costs: 12 Ways You Can Rein Them in, from the Harvard Health Letter 2Health News:Runaway Health Care Costs: 12 Ways You Can Rein Them in, from the Harvard Health Letter 3Health News:Pennsylvanians Encouraged to Take Another Look at COBRA Options 2
(Date:9/22/2014)... PHOENIX , Sept. 22, 2014  For ... wrists, surgery often means facing the prospect of ... can be imagined, regular activities are also impacted, ... on the severity of the problem, some patients ... braces, which can even lead to permanent damage ...
(Date:9/22/2014)... Sept. 22, 2014  Inovio Pharmaceuticals, Inc. (NASDAQ: ... initiated a phase I clinical trial in patients ... safety, tolerability, and immunogenicity of INO-3106. This immunotherapy ... most aerodigestive cancers. Aerodigestive cancers affect ... and parts of the esophagus and windpipe. The ...
(Date:9/22/2014)... , Sept. 22, 2014  CorMedix Inc. (NYSE ... and commercializing therapeutic products for the prevention and ... pleased to announce that TUV-SUD and The Medicinal ... (MEB) has granted its request for a ... Neutrolin was initially approved in July 2013 for ...
Breaking Medicine Technology:Phoenix Arizona Hand Doctor Develops Revolutionary New Surgery System, Eliminates Need for Large Incisions 2Inovio Pharmaceuticals Expands HPV Immunotherapy Development to Aerodigestive Cancers 2Inovio Pharmaceuticals Expands HPV Immunotherapy Development to Aerodigestive Cancers 3Inovio Pharmaceuticals Expands HPV Immunotherapy Development to Aerodigestive Cancers 4Neutrolin Label Expansion Approved for the European Union 2Neutrolin Label Expansion Approved for the European Union 3
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: