Dive Brief:
- Abbott said last week that it has received clearance to sell a device for treating life-threatening openings in the hearts of premature infants.
- The Food and Drug Administration clearance and CE mark position Abbott to sell its Amplatzer Piccolo Delivery System in the U.S. and the European Union.
- Physicians can use the system to deliver Abbott’s Amplatzer Piccolo Occluder to close a hole in the heart, known as a patent ductus arteriosus, or PDA, in premature babies.
Dive Insight:
The Amplatzer Piccolo Occluder is used in the minimally invasive, transcatheter treatment of PDA. While PDA is rare in children born at term, it affects up to 30% of babies who weigh less than 2.5 kg at birth. Authorities in the U.S. and EU authorized the Amplatzer Piccolo Occluder in 2019. Years of real-world use of the occluder have informed the design of the new delivery system.
Sandra Lesenfants, senior vice president of Abbott's structural heart business, said in a statement that the company designed the newly cleared Amplatzer Piccolo delivery device based on physician feedback. The feedback informed a design that is intended to make PDA closure procedures safer and easier.
Abbott evaluated its Amplatzer Piccolo Occluder from 2017 to 2019 in a single-arm trial of 200 infants weighing at least 700 g. The company reported a 95.5% implant success rate. The success rate rose to 99% in children weighing 2 kg or less.
While noting that the rate of periprocedural complications was relatively low, physicians identified an opportunity to reduce the risk of adverse events such as device embolization and migration. The risk-mitigation efforts led to guidelines on how to prevent and manage periprocedural complications. The guidelines addressed topics including how to safely deliver Amplatzer Piccolo Occluder.
The newly cleared delivery device slots into a structural heart portfolio that grew 13.6% in the third quarter. Structural heart was one of five segments within Abbott’s medical device unit that delivered double-digit growth in the quarter.
