Abbott heart device for newborns shows longer-term benefits with three-year data

Dive Brief:

Abbott has presented updated data on its treatment for premature infants with a heart defect, revealing that 95.5% of patients were alive after three years.
The device, Amplatzer Piccolo Occluder, won Food and Drug Administration approval in 2019 and was linked to a 95.5% implant success rate in the first release of clinical trial data in 2020.
Abbott’s follow-up data shows the self-expanding, wire mesh device delivers positive long-term outcomes, giving the company additional evidence to point to as it seeks to position the product as an alternative to medical management or surgical ligation.

Dive Insight:

The heart defect, patent ductus arteriosus, makes it hard for babies to breathe normally and is found in up to 50% of premature babies and more than 80% of severely premature babies weighing less than 2.2 pounds at birth. Prior to the development of Piccolo, physicians either provided medical management to give the defect time to heal or performed surgery. Transcatheter closure was reserved for larger infants.

In a statement, Evan Zahn, director of the Guerin Family Congenital Heart Program at Cedars-Sinai Medical Center, said many patients with the defect “require urgent treatment to survive but aren't responding to medical management and are at high risk for surgery.”

Abbott’s 95.5% implant success rate suggested Piccolo may be a better option in some patients, but it previously lacked data on longer-term patient outcomes. The company used the Pediatric and Congenital Interventional Cardiovascular Society Symposium to address that gap in the evidence.

In addition to the 95.5% three-year survival data and absence of procedure-related deaths, Abbott reported a 2% rate of serious adverse events. No patients suffered device-related events one year or more after implantation.

The device, which is smaller than a pea, is inserted through an incision in the leg and guided through the blood vessels to the heart. Upon reaching the heart, the device is released to seal the defect and thereby enable blood to flow properly.