The USFDA has approved a drug–device combination of furosemide injection for treating edema in adult patients with chronic heart failure. Furosemide, a loop diuretic, helps reduce fluid overload by promoting diuresis.
The newly approved device is designed to deliver subcutaneous infusions of furosemide outside of healthcare settings, allowing select patients to receive treatment without direct supervision from a healthcare professional. The system comprises : A reusable unit, operable up to 48 times A sterile, single-use plastic unit that holds a pre-filled glass cartridge containing 80 mg of furosemide in 2.67 mL A micropiston pump, a needle insertion and retraction mechanism, and a 29-gauge needle Clinical evidence In a clinical trial, the furosemide drug–device combination demonstrated complete bioavailability (112%), achieving similar diuresis (115%) and natriuresis (117%) compared…
