The Food and Drug Administration (FDA) approved Amplatzer Piccolo Occluder, a self-expanding wire mesh device to be used in the closure of patent ductus arteriosus (PDA) an abnormal communication between aorta and pulmonary artery in premature infants.
Each year about 60,000 infants are born prematurely in the United States -- including nearly 12,000 with a PDA large enough that may cause symptoms. These patients may not respond to medical management, and due to their small size, may be at high-risk for corrective surgery.
The device is threaded into the PDA using a catheter that is advanced through the femoral vein or artery in the groin, with a minimally invasive procedure thus demanding surgery for these premature babies that weight as little as two pounds is avoided.
The FDA approved the occluder based on the ADO II trial that evaluated the occluder on 50 patients with a PDA who were older than three days. The safety and efficacy of the device was further supported by additional experience involving 150 more patients. The device builds on more than 20 years of clinical experience with the Amplatzer™ Duct Occluder II a product, already approved for use in the U.S., Europe and countries around the world to treat PDA in larger size pediatric patients and also validated in 6,896 very preterm infants, less than 31 weeks of gestation, in the EPICE cohort study.
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