CHF Solutions (NSDQ: CHFS), formerly known as Sunshine Heart, said today that researchers at Stanford University School of Medicine’s dept. of pediatrics won FDA investigational device exemption approval to initiate a study of its Aquadex FlexFlow aquapheresis system.
The Aquadex FlexFlow is an aquapheresis system designed for diuretic-resistant fluid overload in children with decompensated heart failure, the Eden Prairie, Minn.-based company said.
In the clinical study, researchers will assess 45 children to young adults ages 6 months to 21 years with heart failure and diuretic-resistant fluid overload to evaluate the safety and effectiveness of the Aquadex FlexFlow system.
Researchers aim to determine whether aquapheresis therapy is associated with greater weight loss and a non-inferior rate of renal dysfunction compared to current optimal medical therapy. They will also evaluate impact of heart failure symptoms using a novel pediatric heart failure symptom score, adverse outcomes and need for medical management as secondary endpoints.
“We are pleased that the researchers have received FDA approval to proceed with this IDE study. 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,” CEO & chair John Erb said in a press release.
In April, the company closed an underwritten public offering, bringing in approximately $9.2 million in gross proceeds. The round included the full exercise of the underwriter’s over-allotment option to purchase additional shares, CHF Solutions said.