Abbott launches Amplatzer newborn congenital heart defect trial

Abbott (NYSE:ABT) said today it launched a US pivotal trial looking to explore the safety and effectiveness of a modified version of its Amplatzer device designed to correct patent ductus arteriosus, a congenital heart defect in pre-term infants.

“Patent ductus arteriosus is one of the most common heart defects, accounting for 5% to 10% of all congenital heart disease. Surgery has many risks in this delicate population and a minimally invasive approach is desperately needed,” principal investigator Dr. Evan Zahn of Los Angeles’ Cedars-Sinai Heart Institute said in a prepared statement.

Patent ductus arteriosus is a life-threatening vascular pathway or duct in the heart that remains open due to a failure in the fetal duct to close after birth, Abbott said. The duct serves as a bridge between blood vessels and is located between the main 2 arteries existing the heart, and normally seals itself after birth. In particular cases, the PDA fails to close and can result in serious difficulty breathing and inability to feed.

Abbott said it is developing a version of the Amplatzer device, which has already been approved in Europe, to provide a nonsurgical treatment option for closing PDA defects in newborns and pre-term infants. The device is a wire mesh placed non-surgically through a catheter, inserted through the leg and guided through the vessels to the heart, to seal the duct.

“This modified Amplatzer device has been designed with our youngest and tiniest patients in mind. These smaller sizes may offer physicians greater flexibility to hopefully help these infants live healthy, normal lives,” Abbott structural heart biz VP Michael Dale said in a press release.

The study is slated to enroll approximately 50 patients at 10 centers in the US, with the 1st 7 patients already enrolled at Memphis, Tenn.’s Le Bonheur Children’s Hospital, treated by Dr. Shyam Sathanandam, Abbott said.

The company said it is hopeful that trial results will support an eventual FDA submission for approval.

Yesterday, Abbott said it is upgrading the implantable pacemakers and defibrillators it acquired when it paid $25 billion for St. Jude Medical earlier this year, seeking to move beyond battery and cybersecurity issues that haver plagued it for a year.

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