The U.S. FDA (Food and Drug Administration) has just sanctioned a device from one of the most normal life-threatening medical conditions for prematurely born babies. The Amplatzer Piccolo occluder is the first-ever medical device that could be inserted in the smallest babies (weighing only 2 Pounds) using a minimally invasive method to treat PDA (patent ductus arteriosus). The Amplatzer Piccolo is a device that is smaller than a pea and presently gives hope to premature newborns and infants who require corrective treatment, and who might be non-responsive to medical supervision and has a high risk to experience corrective surgery.
Reportedly, PDA is a possibly life-threatening opening amid two blood vessels starting from the heart. This channel—which is there in generally developing fetuses—is significant before birth to let oxygen-rich blood to flow from the mother in all over the fetus’ body. For most of the infants, the duct or pathway seals itself soon after birth. And in some cases, mostly in babies who are born prematurely, the PDA fails to impulsively close, which can make it tough for babies to inhale or breathe normally owing to raised blood flow to the lungs. PDA reports for almost 10% of all congenital heart disorders. Around 60,000 babies in the U.S. are born prematurely every year with very less birth weight, and about 12,000 (1 out of 5) of these have a hemodynamically important PDA—a PDA which is big and induces symptoms—which will need pressing treatment for the baby to survive.
Lately, the FDA was also in news as its advisors support febuxostat for gout in spite of potential CV (cardiovascular) risk. The FDA advisors overpoweringly voted that the advantages of Uloric (urate-lowering febuxostat) outweigh its dangers for selected gout individuals, though most backed broad unobstructed access is only as second-line therapy. The members voted 19 to 2 that a patient populace survives for whom febuxostat’s benefit-to-risk ratio is constructive in its present indication as first-line treatment to cure hyperuricemia in gout, in spite of a known connection to cardiac deaths.