Navigation Links
PLC Systems Provides Update on Japanese Approval Process for RenalGuard®
Date:1/5/2012

MILFORD, Mass., Jan. 5, 2012 /PRNewswire/ -- PLC Systems Inc. (OTC: PLCSF), a company focused on innovative medical device technologies, announced today that Dr. Ichiro Michishita, a leading Japanese cardiologist, has successfully completed two cases utilizing RenalGuard® for the prevention of Contrast-Induced Nephropathy (CIN) at Yokohama Sakae Kyosai Hospital, Yokohama, Japan. This is the first step in the process to secure regulatory approval for RenalGuard in Japan.

Dr. Michishita, Director of the hospital's Cardiovascular Division, a leading Japanese expert in CIN prevention, has worked with the Japanese Ministry of Health, Labor and Welfare (MHLW) to outline a process for RenalGuard evaluation and approval in Japan. The first step, now completed, was the initial experience of two patients.  Dr. Michishita will meet with the Ministry in February to present these findings and request approval for the previously-agreed upon 60 patient study that could begin as early as April 2012 with Dr. Naoto Inoue, who is the director of Cardiovascular Center of Sendai Kousei Hospital, as the co-investigator.  The investigators expect to complete that study within 8-10 months.  Once the study is concluded, the results will be submitted to the MHLW, as part of a package for shonin approval from the agency.  Completion of this process, if successful, would allow the importation of RenalGuard for sales and marketing in Japan. 

Mark R. Tauscher, President and Chief Executive Officer of PLC, said, "We are absolutely delighted by the positive experience of these initial cases utilizing RenalGuard in Japan.  Dr. Michishita's leadership in CIN prevention is paving the way for the clinical study that hopefully will lead to the approval by the MHLW to allow us to begin selling RenalGuard in Japan. The Japanese market is arguably the second largest market in the world for RenalGuard, based upon the number of cath lab procedures and patients undergoing these procedures with existing at-risk conditions for CIN.  We await approval of the larger patient study shortly, and following the successful completion of the trial, approval for the start of sales and marketing of RenalGuard in Japan, launching a major new phase in RenalGuard's adoption."

Dr. Michishita noted, "I am very pleased that the very first cases utilizing RenalGuard in Japan to prevent CIN were successful. I am very impressed with the ease of use of the system, and how it works to maintain the fluid balance of the body. Once it is approved by the MHLW, I believe that RenalGuard will be a great benefit for patients undergoing PCI requiring contrast media."

Contrast-Induced Nephropathy

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. More than 7 million such imaging procedures occur worldwide each year, and it is estimated that 15-20% of those patients are 'at risk' of acquiring CIN. CIN is the third most common cause of in-hospital acute renal failure.  It is associated with significant in-hospital mortality rates, and increases in long-term mortality rates, major in-hospital adverse cardiac events, and increased risk of renal dialysis therapy.  All of these lead to prolonged hospital stays and increased medical costs.  Estimated mortality rates for patients who acquire CIN may be as high as 35%. 

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. Life Recovery Systems Receives European CE Mark Approval for Its ThermoSuit(R) System
2. Flexible Medical Systems Raises $1.2M Seed Investment for Initial Human Trials
3. Boston Scientific to Release Broad Range of Clinical Trial Data Reinforcing Safety and Efficacy of Taxus(R) Coronary Stent Systems at TCT 2007
4. BD and PEPFAR Collaborate to Strengthen Laboratory Systems in Fight Against HIV/AIDS and TB
5. Imaging Diagnostic Systems CTLM Technology Presented at Congress of World Society for Breast Health
6. Imaging Diagnostic Systems Updates PMA Filing Status for the New CT Laser Breast Imaging System
7. PLC Systems Achieves Successful Early Conclusion of RenalGuard(TM) Pilot Safety Trial
8. PLC Medical Systems Names Lead Investigators for Pivotal Trial to Evaluate RenalGuard System(TM) and RenalGuard Therapy(TM)
9. Pharmatech Teams up With Systems Medicine LLC and the Sarcoma Foundation of America for a Phase II Myxoid Liposarcoma Trial
10. PLC Systems Reports Fourth Quarter 2007 Results
11. PLC Systems Receives FDA Approval to Commence Pivotal Study Of RenalGuard(TM) In the U.S.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016 ... the "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" ... In-Mold Electronics, Smart Skin, Structural ... Structural electronics involves electronic and/or ... protective structures, replacing dumb structures such as vehicle ...
(Date:6/24/2016)... 2016 Research and Markets has announced ... Diagnostic Tests" report to their offering. ... The World Market for Companion Diagnostics covers ... Market analysis in the report includes the following: ... Diagnostic Kits) by Region (N. America, EU, ROW), 2015-2020 ...
(Date:6/24/2016)... , June 24, 2016  Arkis BioSciences, a ... invasive and more durable cerebrospinal fluid treatments, today ... The Series-A funding is led by Innova Memphis, ... and other private investors.  Arkis, new financing will ... and the market release of its in-licensed Endexo® ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. ... from injury. Recently, he has implemented orthobiologic procedures as a method for treating ... one of the first doctors to perform the treatment. Orthobiologics are substances that ...
(Date:6/24/2016)... Angeles, CA (PRWEB) , ... June 24, 2016 , ... ... surgery procedures that most people are unfamiliar with. The article goes on to state ... procedures, but also many of these less common operations such as calf and cheek ...
(Date:6/24/2016)... ... ... a crisis. Her son James, eight, was out of control. Prone to extreme mood shifts ... upset him, he couldn’t control his emotions,” remembers Marcy. “If there was a knife ... and say he was going to kill them. If we were driving on the ...
(Date:6/24/2016)... Francisco, CA (PRWEB) , ... June 24, 2016 ... ... CitiDent, is now offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive ... self-ligating Damon brackets , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation ...
(Date:6/24/2016)... ... June 24, 2016 , ... People across the U.S. are sharpening ... Talker Award, an essay contest in which patients and their families pay tribute to ... at the 2016 National Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this ...
Breaking Medicine News(10 mins):