CHF Solutions, Inc (CHFS)

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CHF Solutions' Aquadex FlexFlow(R) Aquapheresis System Receives FDA IDE Approval for Clinical Study for Pediatric Use
1 day 3 hours 19 minutes ago - DJNF

CHF Solutions' Aquadex FlexFlow(R) Aquapheresis System Receives FDA IDE Approval for Clinical Study for Pediatric Use
EDEN PRAIRIE, Minn., June 29, 2017 (GLOBE NEWSWIRE) -- CHF Solutions, Inc., (fka Sunshine Heart, Inc.) (NASDAQ:CHFS) announced today that researchers in the Stanford University School of Medicine's Department of Pediatrics have received FDA Investigational Device Exemption (IDE) approval to conduct a clinical study to evaluate the safety and effectiveness of CHF Solutions' Aquadex FlexFlow Aquapheresis System for diuretic-resistant fluid overload in children with acute decompensated heart failure. The randomized multi-center, non-blinded clinical study will assess up to 45 children and young adults ages 6 months to 21 years with heart failure and diuretic-resistant fluid overload. Heart failure is the leading cause of death in children with cardiomyopathy and congenital heart disease.

The study seeks to determine whether Aquapheresis therapy is associated with greater weight loss and a non-inferior rate of renal dysfunction compared to optimal medical therapy. In addition, the impact on heart failure symptoms using a novel pediatric heart failure symptoms score developed by the investigators, adverse outcomes and the need for medical management will be evaluated as secondary endpoints. The study is being led by Stanford's Christopher Almond, Associate Professor of Pediatrics (Cardiology), and David Kwiatkowski, Clinical Assistant Professor of Pediatrics (Cardiology).

"We are pleased that the researchers have received FDA approval to proceed with this IDE study," said John Erb, Chairman and CEO of CHF Solutions. "Given the limitations of patient unresponsiveness to diuretic therapies over time, our solution represents a potentially transformative future standard of care. We look forward to the clinical data results and to continuing our efforts to provide patients with additional treatment options for the treatment of heart failure," Mr. Erb concluded.