Abbott’s Amplatzer Piccolo Occluder Receives FDA Approval, a Medical Device for Premature and Newborns with Patent Ductus Arteriosus (PDA)
Abbott’s Amplatzer Piccolo Occluder Receives FDA Approval, a Medical Device for Premature and Newborns with Patent Ductus Arteriosus (PDA)
Shots:
- The approval is based on ADO II AS study results assessing the Amplatzer Piccolo in 50 patients with PDA older than three days across eight centers in the US, with safety and efficacy supported by additional trial in 150 patients
- Amplatzer Piccolo Occluder is a self-expanding, wire mesh medical device inserted in the leg and is transported to the heart through veins allowing physicians to insert it through the aortic or pulmonary artery for closing the opening in the heart
- The pea-sized medical device is implanted in babies weighing two pounds to treat PDA and is approved post-Masters HP mechanical heart valve of 15mm, for treatment of high-risk pediatric patients with a congenital heart defect
Click here to read full press release/ article | Ref: Abbott| Image: Mass Device