The Aquadex FlexFlow system is a clinically proven therapy that provides a safe, effective, and predictable method of removing excess fluid
Image: CHF Solutions submits 510(k) application for Aquadex FlexFlow System. Photo: Courtesy of The U.S. Food and Drug Administration/Wikipedia.
CHF Solutions has submitted an application to the FDA requesting for 510(k) clearance of the Aquadex FlexFlow system to include pediatric patients who weigh 20kg or more. Subject to FDA review, the company expects clearance for this pediatric population by the end of the year.
“We are excited to have achieved this significant milestone in our corporate strategy to make the Aquadex FlexFlow technology available to pediatric patients,” said John L. Erb, chairman and CEO of CHF Solutions. “Following FDA clearance, we look forward to expanding use for these most vulnerable patients, who have limited alternative solutions.”
“We are pleased with CHF Solutions’ commitment to taking the regulatory steps to support our efforts in delivering this therapy to pediatric patients,” said Dr. Stuart L. Goldstein, Director of the Center for Acute Care Nephrology at Cincinnati Children’s Hospital Medical Center. “Devices like this will address a significant unmet need in the treatment options available to children.”
The Aquadex FlexFlow system is a clinically proven therapy that provides a safe, effective, and predictable method of removing excess fluid from patients suffering from fluid overload. The Aquadex FlexFlow system is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and for extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization. The company has submitted an application to the FDA requesting for 510(k) clearance of the Aquadex FlexFlow system to include pediatric patients who weigh 20kg or more. All treatments must be administered by a healthcare provider, under physician prescription, both of whom having received training in extracorporeal therapies.
Source: Company Press Release