RenalGuard Therapy(R) Shows Promise in TAVI Procedures
Data Presented at European Medical Conference
MILFORD, MA -- (Marketwired) -- 05/28/13 -- PLC Systems Inc. (OTCQB: PLCSF), a company focused on innovative medical device technologies, today announced that Dr. Vaikom Mahadevan presented RenalGuard® data during the Interventions for Structure Heart Disease session at EuroPCR, the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). The data presented supports the further development of RenalGuard Therapy® to minimize Acute Kidney Injury (AKI) in patients undergoing Transcatheter Aortic Valve Implantation (TAVI) procedures.
Dr. Vaikom Mahadevan, Consultant Cardiologist at Manchester Royal Infirmary, commented, "RenalGuard has performed very nicely in this difficult patient population. My experiences so far lead me to believe that RenalGuard can be used effectively as a treatment for TAVI patients with renal impairment to reduce the risk of renal function deterioration."
In his presentation titled, "Minimizing Acute Kidney Injury During TAVI Procedures," Dr. Mahadevan shared data from patients on RenalGuard during a TAVI procedure. The results showed that the RenalGuard Therapy can be used safely in patients undergoing TAVI using general anesthesia.
Acute Kidney Injury (AKI) is a significant complication of TAVI, a minimally invasive procedure for replacing diseased aortic valves in patients that are not candidates for cardiac surgery. According to data published in EuroIntervention in 2012, the incidence of AKI after TAVI is very high. Numerous studies have shown that the development of AKI after TAVI leads to significantly worse long-term outcomes, including increased mortality after one year.
The therapy delivered by the RenalGuard system is based on the theory that creating and maintaining a high urine output can improve renal function. RenalGuard is intended to achieve high urine output safely by automatically and continuously measuring 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.
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 Nephropathy (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, 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.
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Source: PLC Systems, Inc.
Released May 28, 2013