MILFORD, MA--(Marketwired - Sep 11, 2013) - PLC Systems Inc. (
Mark R. Tauscher, President and CEO of PLC Systems, stated, "TAVI is one of many in-hospital procedures that can lead to Acute Kidney Injury -- AKI. This hospital-initiated study will be a major contribution to the science of AKI in these high profile TAVI cases. We are excited that Dr. Arbel is using the RenalGuard therapy on TAVI patients which supports our commitment to expand patient use of our RenalGuard therapy which is based on the theory that creating and maintaining a high urine output can improve kidney function."
The trial will evaluate whether forced diuresis with matched hydration will reduce the incidence of contrast induced nephropathy in patients undergoing TAVI. Patients will be randomized to receive either RenalGuard or placebo comparator. The primary endpoint is the reduction of acute kidney injury at 48-72 hours. More information about the trial can be found at http://clinicaltrials.gov/ct2/show/study/NCT01866800.
TAVI is a minimally invasive procedure for replacing diseased aortic valves in patients that are not candidates for cardiac surgery. However, a significant complication of these procedures is Acute Kidney Injury (AKI). According to data published in EuroIntervention in 2012, the incidence of AKI after TAVI is as high as 36%. Numerous studies have shown that the development of AKI after TAVI leads to significantly worse long-term outcomes, including increased mortality after one year.
AKI is characterized by a rapid reduction in kidney function resulting in a failure to maintain fluid, electrolyte and acid-base homoeostasis. According to the Renal Association, an estimated 5-20% of critically ill patients experience an episode of AKI during the course of their illness. AKI can be fatal and requires intensive treatment.
RenalGuard is intended to prevent AKI by achieving high urine output safely through automatic and continuous measuring of the patient's urine output and matching that volume by infusing an equal volume of hydration fluid. RenalGuard allows patients to receive as much fluid as they produce while minimizing the risk of over- or under-hydration. In two previously conducted studies, RenalGuard Therapy® has been shown to reduce the incidence of acute renal failure following cardiac catheterization.
About PLC Systems Inc.
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 rapidly remove contrast dyes that are potentially toxic to 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 Contrast-Induced Acute Kidney Injury (CI-AKI). RenalGuard is being studied in a pivotal trial in the U.S., as part of the FDA approval process. For more information, visit www.plcmed.com, or connect with the Company on Facebook, Twitter, LinkedIn, YouTube and Google+.
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, 2012, 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.