Due to inadequate vascular space to accommodate pacemaker leads and delivery tools, children often require median sternotomy or thoracotomy to access the epicardial surface, and invasive procedure that requires lengthy hospital stays and intensive care. PeriPath offers a percutaneous pericardial approach for the placement of epicardial leads, that can be fixated to the heart of a child with a smaller and less invasive incision. NCC-PDI provided $50,000 in direct funding, and consultation services for animal trials, engineering, and regulatory activities.
Year:
2016
Anticipated Classification:
Class II
Anticipated Regulatory Path:
510(k)
Initial Development Stage:
Pre-clinical
Current Development Stage:
Pre-clinical
