We just learned of a new coronary stent from ITGI Medical of Or Akiva, Israel that has recently started being used in Europe. Called Over and Under® Pericardium Covered Stent (PCS), the device is thought to be indicated for the treatment of bypass stenosis (as in degenerated Saphenous Vein Graft (SVG) in patients who are status post CABG), as well as for aneurysms and for emergency situations such as perforations.
Here’s what Frost and Sullivan, a consultancy firm, thought about the device and the future for its clinical applications:
In order to address problems that may compound due to events triggered by arterial lumen renarrowing and thrombosis, and the need to avoid the use of antiplatelet therapy, Or Akiva, Israel based ITGI Medical Ltd., has developed a stent that is covered with heterologous tissue. Called the Over and Under Pericardium Covered Stent (PCS), the scaffold sets a barrier between the coronary blood vessel wall and its lumen. What makes the product unique is that it is 100% covered, is biocompatible, and is highly flexible. Typical indications would include the use of these in situations such as degenerated saphenous vein graft (SVG), aneurysms and perforations. Talking to Technical Insights on the basis of having developed a pericardial tissue covered stent, Efri Argaman, CEO said, "The stenting market is divided between different segments and about 85% of the indications make use of the bare metal stents or the drug eluting stents currently available. The relatively big niche of indication within the coronary arena, which translates to about 10% of the total stent market, requires the separation of the blood from the blood vessel wall and the lumen. Our company has exclusively forayed into this segment that has involved indications of plaque inside the saphenous vein graft and coronary aneurysms largely."
The Over and Under heterologous PCS has a stainless steel structure that has been specially designed to host a pericardium cylinder and can be used to create an expandable graft. Some of the advantages would include a low-profile feature allowing deployment in narrow lumens, achieved through low pressure of 5 atmospheres. This reduces the risk for ruptures and restenosis. The flexible nature of the stent allows for navigation through the tortuous vessel. The equine pericardium used over the stent is highly flexible and provides 100% coverage. Talking further on the use of equine pericardial tissue, Argaman said, "The issue of biocompatibility in small diameters made us choose a biomaterial that was highly biocompatible and stronger than the existing polymer material, eptfe (polytetrafluoroethylene)."
Future applications include the use of Over and Under for brain aneurysms due to its ability to isolate the aneurysm from the blood system and its use in the hepatic artery.
Product page: Over and Under® Pericardium Covered Stent …
Press release: ITGI Medical launches Over and Under® Pericardium Covered Stent in England, Switzerland and Ireland (.pdf)…