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Aortix - Fontan

Project Lead: Procyrion
Year: 

2014

Anticipated Classification:

Class III

Anticipated Regulatory Path:

PMA

Initial Development Stage:

Concept Formation

Current Development Stage:

Prototyping

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.

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