The Over and Under^® Pericardium Covered Stent (PCS) is a unique stent, first in a series of heterologous tissue covered stents, designed to set a barrier between the blood vessel wall and its lumen. The Over and Under^® PCS is indicated for post PTCA treatment of Saphenous Vein Graft (SVG) stenosis, aneurysms and for emergency situations such as perforations. The Over and Under^® Pericardium Covered Stent is intended to be used in application where complete separation between the blood flow and the arterial wall is required. Specifically, it is intended for intraluminal chronic placement after PTCA procedures that have been performed in coronary arteries, aorta-coronary bypass grafts, or suitable size vessels. It may be used for the following indications: Coronary Bypass-Vein Graft Stenosis, Coronary Bypass-Vein Graft Aneurysm. In emergency situations the device also can be used for: Acute Coronary Artery Perforation, Acute Coronary Artery Rupture, and Coronary Artery Aneurysm.

The Over and Under^® PCS is a percutaneous implantable device consisting of a 316L stainless steel bare metal stent covered by an equine pericardium cylinder. The Pericardium cylinder is sutured with a polypropylene suture onto the bare metal stent.

The covered stent is available in diameters of 2.5mm, 3.0mm, 3.5mm, and 4.0mm, and lengths of 13, 18, 23 and 27 mm. The stent is mounted on a balloon catheter. The balloon nominal diameter is identical to the corresponding inner lumen stent diameter, balloon lengths are 15, 20, 25 and 30mm.

1. The device is 6Fr guiding catheter compatible for the 2.5mm, 3.0mm, 3.5mm and 7Fr guiding catheter compatible for the 4.0mm. The device is compatible with 0.014” guide wires.
2. The distal end of the balloon catheter is packaged in a tubing called “wet container”. The product’s distal end is chemically sterilized inside the wet container. After chemical sterilization, the sterilant is removed from the wet container, and storage solution added. The product is further placed on a sealed tyvek tray,  sterilized using Ethylene Oxide and finally packaged in its shipping box.
3. The efficacy of Over and Under^® PCS in treatment of SVG lesions has been demonstrated in the SLEEVE II study resulting in 10.6% MACE at 30 days post hospitalization [data on file, ITGI Medical]. To date, the long term outcome of PCS implantation in SVG lesions and coronary artery aneurysms has not been determined. Currently a registry is being conducted that will track the safety and efficacy of PCS with long term follow up to 3 years.