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Multi-Center, Retrospective Study Evaluates Use of Ultrafiltration Therapy with Aquadex FlexFlow® System in Pediatric Patients
The study, titled “Kidney Support in Children Using an Ultrafiltration Device,” included 117 patients in three weight categories: <10 kgs; 10-20 kgs; and >20 kgs, suffering from volume overload, acute kidney injury or end-stage kidney disease. All patients across the three weight categories were treated with the Aquadex FlexFlow system, using one of the following three modalities: slow continuous ultrafiltration (SCUF); continuous veno-venous hemofiltration (CVVH); or prolonged intermittent kidney replacement therapy, based on patient condition.
The primary outcome was survival to the end of therapy. In patients weighing over 20 kgs (n=32), 97% survived to the end of therapy. In patients weighing between 10-20 kgs (n=13), 100% survived to the end of therapy. In patients weighing under 10 kgs (n=72), 60% survived to the end of therapy.
“We report the first multi-center experience in pediatrics in which we use an ultrafiltration device to provide kidney support therapy in younger patients," said
As previously announced, the company will be hosting a conference call and webcast with investigators from the study tomorrow,
Certain statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding use of the Aquadex Flex Flow system in pediatric patients. 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 commercialization 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 SEC. Forward-looking statements speak only as of the date when made. CHF Solutions does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Source: CHF Solutions, Inc.