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CHF Solutions receives 510(k) clearance for Aquadex SmartFlow™ system in Pediatric Patients Weighing 20kg or More
In a retrospective, multi-center study, 32 pediatric patients weighing over 20 kgs and predominantly suffering from hypervolemia were treated with the Aquadex system and 97% (31/32) survived to the end of therapy.1
“For many types of pediatric patients, the available therapies require very high relative extracorporeal blood volumes, which can be challenging,” said
“With the approval of the Aquadex SmartFlow, traditionally underserved pediatric patients will benefit from ultrafiltration therapy that has shown positive clinical results and has strong interest from pediatric hospitals,” said
About the Aquadex SmartFlow System
The Aquadex SmartFlow system is a clinically proven therapy that provides a simple, flexible, and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a healthcare provider, within an outpatient or inpatient clinical setting, under physician prescription, both of whom having received training in extracorporeal therapies.
Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements about the clinical use of the Aquadex SmartFlow system in adult and pediatric patients weighing 20kg or more. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risk associated with our ability to execute on our commercial strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the
Source: CHF Solutions, Inc.