Joseph Dearani
The purpose of this study is to test the safety and performance of a new blood vessel graft, called the ATEV. The graft is designed to reconnect the heart to the lungs and to grow as the child grows, which may eliminate the need for future surgeries.
Inclusion Criteria * Discontinuous pulmonary arteries requiring conduit placement. * Normal branch pulmonary arteries, with no evidence of hypoplasia or stenosis of distal branches of pulmonary arteries, measured from the hilar pulmonary artery. * No evidence of pruning, lack of pulmonary artery lung distribution, evidence of focal stenosis, aortopulmonary collaterals or filling defects. * The proximal portion of the targeted parenchymal pulmonary artery has a minimum diameter of 4mm. * No history of systemic-pulmonary shunt placement. * Age 6 months - 2 years (to maximize direct patient bene…
A sterile, single-use acellular vascular graft/conduit surgically implanted once to restore pulmonary blood flow from the main pulmonary artery to the lung in infants with discontinuous pulmonary arteries. Participants receive standard perioperative care and post-implant antithrombotic therapy per protocol.
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