Aortix-Fontan is a long-term, catheter-deployed mechanical circulatory support system that is implanted in the cavopulmonary connection to act as a primer for single ventricle physiologies. Each pumping unit of the device consists of non-obstructive pump housing and inflow cannula with an expandable strut section that anchors to the cavopulmonary wall; a pump assembly that contains a motor, impeller, stator, and self-centering outflow nozzle; and a thin, flexible power lead that can be anchored to the vessel exit site and tunneled subcutaneously. NCC-PDI has provided feedback and guidance based on the initial application and proposal presentation. Additionally, the NCC-PDI administration has put Procyrion in contact with regulatory advisors and has offered support ranging from engineering to clinical consulting and provided guidance on SBIR submission. NCC-PDI also suggested a number of Federal and non-Federal funding sources focused on pediatric medical device innovation.
Year:
2014
Anticipated Classification:
Class III
Anticipated Regulatory Path:
PMA
Initial Development Stage:
Concept Formation
Current Development Stage:
Prototyping
