June 3, 2008 - The CE certified Over and Under Pericardium Covered Stent (PCS) commercial implantation and first implantation in the U.K. was performed at the Royal Bournemouth Hospital, representing the use of a new approach that may usher in a new era for interventional medicine.
Over and Under is a stent 100 percent covered with a heterologous tissue, designed to set a barrier between the coronary blood vessel wall and its lumen. It is intended for situations such as degenerated Saphenous Vein Graft (SVG), aneurysms and perforations.
The Percutaneous Coronary Intervention Leader Suneel Talwar, M.D., and the Cath Lab Director Rosie Swallow, M.D., performed the procedure. The medical team deemed it as a success due to the special characteristics of the stent and the ease at which the stent was delivered to the lesion.
A pilot study designed to compare the deliverability of a PTFE covered stent versus Over and Under PCS was presented by Haim Danenberg, M.D., head of the Interventional Cardiology Unit and the company's medical director, at the annual EuroPCR meeting. Study was performed in phantom and porcine coronaries. Over and Under PCS appeared to be significantly superior in deliverability in both model systems.
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