The 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.. Under investigation is a Pericardium Covered Stent (PCS) intended to be used for endovascular treatment of intracranial aneurysms, carotid cavernous fistuals and intracranial dissections.

Twenty percent of endovascular treatments in aneurysms are ineffective and recurrent. Treatment of these aneurysms with coils and stents has proven ineffective and has resulted in recanalization of the aneurysm. Carotid-Cavernous Fistulas can be treated effectively without sacrificing the carotid artery and in one step with a covered stent. In dissections a covered stent can repair immediately the vessel wall and no need to sacrifice the vessel or to wait until it repairs with a regular stent. The major advantage is that in one action, complete occlusion of the aneurysm, fistula or dissection is attained without multiple insertions of coils, remodeling balloons, or a stent and coils.

The 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 PCS 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 stent diameter, and lengths are 15, 20, 25 and 30mm respectively.

The device is 6Fr guiding catheter compatible for the 2.5mm, 3.0mm, 3.5mm and 4.0mm diameters. The device is compatible with 0.014” guide wires.

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. After chemical sterilization, the fluid sterilant is removed from the wet container, and storage solution added. The product is further sterilized using Ethylene Oxide and finally packaged in a carton.

Prior to insertion, the device is removed from the wet container and rinsed for at least 2 minutes in sterile saline. The guide wire lumen is rinsed using the purging needle provided. The device is then mounted on the coronary guide wire, advanced to the target location and deployed using standard interventional technique.

The PCS was CE marked in May 2006. The first use in clinical practice started in May 2007. The balloon expandable PCS is intended for intra-luminal chronic placement in native coronary arteries or SVGs treated by PCI. The PCS can be implanted for SVG stenosis and treatment of coronary artery aneurysms. The PCS has also been used to successfully treat coronary artery perforation and rupture in emergency situations. 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. The present registry will track the safety and efficacy of PCS with long term follow up to 3 years.

AneuGraft^® is CE Marked for use of coronary SVG, Aneurysm and perforations.