Baptist Cardiac and Vascular Institute : Humanitarian Device Exemptions 

A Humanitarian Use Device is approved by the Food and Drug Administration (FDA) intended to benefit patients by treating a condition that affects fewer than 4,000 individuals in the United States per year and for which there is no comparable device available to treat a particular condition.

ENTERPRISE™ Vascular Reconstruction Device and Delivery System

Sponsored by:  Cordis Neurovascular
This Humanitarian Use Device has been approved by the Food and Drug Administration   for those who have been diagnosed as having a wide-neck, intracranial (in the brain), saccular / fusiform (like a balloon) aneurysm, or has either ruptured (burst open) or unruptured. During the procedure to treat the aneurysm the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System will be used to aid in treating this medical condition.
Principal Physician:  Italo Linfante, MD

Wingspan™Stent System with Gateway PTA Balloon Catheter

Sponsored by Boston Scientific
The Wingspan™Stent System with Gateway PTA Balloon Catheter is a stent used to treat arteries blocked by intracranial atherosclerotic disease.  The purpose of the stent is to open the artery and increase the blood flow to the brain.
Principal Investigator:  Italo Linfante, MD