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Winthrop University Hospital

JOSTENT GraftMaster

Summary

The clinical study is in place so that the JOSTENT GraftMaster Coronary Stent Graft system is available to those patients who may emergently need it. The FDA has approved the JOSTENT for commercial use in selected patients under a Humanitarian Device Exemption (HDE) for use in the treatment of free perforations in native vessels or saphenous vein bypass grafts greater than or equal to 2.75 mm in diameter.

Description

Winthrop-University Hospital - Division of Cardiology is participating in this clinical study so that the JOSTENT is available to those patients who may emergently need it. A JOSTENT is a special type of stent that can be placed in a patient's coronary artery should a leakage or perforation occur. Such a leakage is rare, but may occur as a complication of the coronary intervention. The JOSTENT is a humanitarian use device (HUD) and is not routinely used. It is used only in a potentially serious and life-threatening situation.

Inclusion/exclusion

The FDA has approved the JOSTENT for commercial use in selected patients under a Humanitarian Device Exemption (HDE) for use in the treatment of free perforations in native vessels or saphenous vein bypass grafts greater than or equal to 2.75 mm in diameter.

Principal Investigator

Kevin Marzo, MD

Department

Division of Cardiology

Email

kmarzo@winthrop.org

Other Contact

For more information please call Research Coordinator at 516-663-8692.
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259 First Street | Mineola NY 11501 | 516-663-0333


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