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:12/25/2014)... 26, 2014 The click ... beauty, strength and durability. Today, the business announces ... is valid until Jan. 30, 2015. , Click ... traditional hardwood. BambooFlooringChina.com is a well-known brand in ... worldwide to find a reliable bamboo flooring supplier. ...
(Date:12/25/2014)... (PRWEB) December 26, 2014 Recently, iFitDress.com, the ... for women, has announced its new selection of black ... are on sale now; they are available at discounted prices, ... says, “The promotion will last for three weeks only. You ... market. Those who are interested in our new items can ...
(Date:12/25/2014)... Hills, California (PRWEB) December 25, 2014 ... her home in Woodland Hills, California after an 8 ... passed away on Christmas Eve evening in her home ... with aggressive metastatic breast cancer. , ... for over forty years, she pioneered and championed many ...
(Date:12/25/2014)... Dec. 25, 2014 (HealthDay News) -- Overeating is common during ... eat in moderation, an expert says. "Don,t arrive at ... calories if you know you,ll be attending a party, but ... Ashbey-Pejoves, lead dietitian at Northern Westchester Hospital in Mount Kisco, ... to eat healthy during the day and even to have ...
(Date:12/25/2014)... 25, 2014 “ SmileStix ” was featured ... the latest and coolest mobile applications on the iOS, Android, ... host of NewsWatch, conducted the app review and shared with ... personal stickers. , The old saying goes, “A picture says ... words that can describe a single image, because each picture ...
Breaking Medicine News(10 mins):Health News:BambooFlooringChina.com: click strand woven bamboo flooring promotion valid until Jan. 30, 2015. 2Health News:iFitDress.com: Black One-Shoulder Cocktail Dresses for 2015 2Health News:RP International founder, Helen Harris Dies on Christmas Eve Just Hours Before Her Holiday Television Broadcast to Raise Funds to Cure Blindness was Broadcasted Nationally 2Health News:RP International founder, Helen Harris Dies on Christmas Eve Just Hours Before Her Holiday Television Broadcast to Raise Funds to Cure Blindness was Broadcasted Nationally 3Health News:RP International founder, Helen Harris Dies on Christmas Eve Just Hours Before Her Holiday Television Broadcast to Raise Funds to Cure Blindness was Broadcasted Nationally 4Health News:An Application to Create Custom Stickers was Featured on NewsWatch Television on December 19, 2014 2
... Oct. 19 Broadband Wireless,International Corporation (Pink Sheets: ... round discussions with Mr. Kenneth Andam in,connection with ... Owing to a continuing business relationship,connecting Mr. Andam ... a,series of good faith negotiations have commenced between ...
... (Nasdaq: ARNA ) announced today that it has ... with the Securities,and Exchange Commission relating to a proposed ... connection with this offering,Arena plans to grant to the ... 1,500,000 shares of common stock to cover over-allotments, if,any. ...
... Oct. 19 Video games it is not. ... (VR),applications have experienced double-digit growth both worldwide and ... and the 2010 U.S. market for virtual,reality in ... grow to,$290 million, according to Virtual Reality Market ...
... less the idea bothered her , , FRIDAY, Oct. 19 ... idea of childlessness than men, new research shows, and ... each gender views the pressures of parenthood. , "On ... parenthood mean different things," said study author Tanya Koropeckyj-Cox. ...
... in Congress, caregivers and advocates,to visit Capitol Hill Tuesday, ... nursing homes, WASHINGTON, Oct. 19 With political ... about the impact of,private equity buyouts of nursing homes, ... in D.C. on Monday where they will hold a,demonstration ...
... under 6, advisers say., , , FRIDAY, Oct. 19 (HealthDay News) ... panel on Friday recommended a ban on over-the-counter cough and ... number of studies that showed the remedies were no better ... be tested on children to see if they are effective. ...
Cached Medicine News:Health News:Broadband Wireless International Corporation Announces the Commencement of Good Faith Talks with HealthPitch 2Health News:Arena Pharmaceuticals Announces Public Offering of Common Stock 2Health News:Virtual Reality Technology Finds Ready and Willing Market in Healthcare 2Health News:Childlessness Bothers Men More Than Women 2Health News:Childlessness Bothers Men More Than Women 3Health News:FDA Panel Recommends Ban on Cold Medicines for Kids 2Health News:FDA Panel Recommends Ban on Cold Medicines for Kids 3Health News:FDA Panel Recommends Ban on Cold Medicines for Kids 4
(Date:12/24/2014)... Dec. 24, 2014  The International Trade Commission (ITC) issued ... against BMC Medical. In a notice issued on December 23, ... ResMed,s patent on its humidifier was invalid. BMC ... win". "We are very excited with the ITC,s decision in ... we have taken since the very beginning on the key ...
(Date:12/24/2014)... 23, 2014 PuraMed BioScience®, Inc., (OTC Pink: ... medicinal and healthcare products, announced it received the initial ... hemp-based, advanced headache relief product, for planned distribution to ... Colorado , Washington State , ... the MigraPure H Advanced headache relief gel formulation completed, ...
(Date:12/24/2014)... Mass. , Dec. 23, 2014   ... ), a biopharmaceutical company developing therapeutic products for ... Medicines Agency (EMA) of the Marketing Authorization Application ... EMA recently granted the company,s request for accelerated ... EMA,s regulatory review time.   The ...
Breaking Medicine Technology:ITC Final Decision Goes Against ResMed (RMD) Monumental Win for 3B/BMC 2PuraMed BioScience Nears Final Stages Needed for Distribution of MigraPure H 2PuraMed BioScience Nears Final Stages Needed for Distribution of MigraPure H 3Synageva BioPharma Announces Sebelipase Alfa Marketing Authorization Application Validated By The EMA 2Synageva BioPharma Announces Sebelipase Alfa Marketing Authorization Application Validated By The EMA 3
... improvement solutions provider General Physics Corporation (GP) , ... GPX ), announced today that it has formalized ... (Seville, Spain), a leading European technology company, to provide ... control technologies to optimize fuel costs and further reduce ...
... Nov. 17, 2011 SurgiCount Medical, Inc., the ... (OTCBB: PSTX, OTCQB: PSTX) today announced that it ... alliance.  A collaboration of more than 2,500 hospitals ... alliance seeks to lead the transformation to high ...
Cached Medicine Technology:GP and INERCO Form Strategic Alliance to Assist Clients with Optimizing Fuel Costs and Decreasing Emissions 2GP and INERCO Form Strategic Alliance to Assist Clients with Optimizing Fuel Costs and Decreasing Emissions 3SurgiCount Medical Announces Agreement with Premier Healthcare Alliance 2SurgiCount Medical Announces Agreement with Premier Healthcare Alliance 3
Ideal for use with our High Beam headlight. Rotating Turret allows use with other manufacturer's cables. Infinite intensity control. Excellent color definition (6000 K Color Temperature)....
... Lite positions directly over one,eye permitting ... lens an exclusive feature ,resulting ... optic light that penetrates,deep into a ... swivel mount enables the,surgeon to rotate ...
Mounted on a fully adjustable molded,headband with crown strap and comfort,cushions, the sturdy Halogen III Classic is,lightweight, comfortable and durable....
... InterGro DBM putty is a ... most trusted names in human tissue ... in bone grafting technology. InterGro ... lipid carrier (lecithin) to deliver a ...
Medicine Products: