Belgian Device Being Marketed in E.U., Still Awaiting U.S. Approval.
The multilayer stent system for aneurysm repair developed by Belgian device-maker Cardiatis, which was approved for use in Europe in 2009 for treatment of peripheral aneurysms and has also been used for cerebral and aortic aneurysms, will be discussed at the 39th VEITHsymposium.
The Cardiatis technology uses a proprietary technique of multilayer braiding of cobalt alloys, to develop stents with spatial three-dimensional geometric structures. That patented design makes it possible for the stent to maintain blood flow through the affected artery and surrounding branches while simultaneously reducing pressure in the aneurysm to prevent rupture and inducing a clot to seal it off. Proponents of the device point to its utility for situations where use of covered stents is not possible, while its critics remain unconvinced that the differential in flow volume actually leads to thrombosis or believe the procedure is more dangerous than normal stent placement.
A special session is being dedicated to discussion and debate on the multilayer stent system, with presentations on its applications for aortic and other aneurysms by vascular surgeons from around the globe. Maria Antonelli Ruffino, M.D., and Claudio Rabbia, M.D., Ph.D., vascular interventional radiologists at the San Giovanni Battista Hospital, (Turin, Italy), will present an overview of their work with the stent for visceral aneurysms; in a previously released study of 19 patients they concluded that the multilayer stent allowed them to overcome limitations of traditional endovascular devices and proved to be a reliable tool for endovascular aneurysms for patients otherwise deemed not suitable for a minimally invasive approach.
Vascular surgeons Claude Vaislic, M.D., Centre Chirurgical Marie Lannelongue (Le Chesnay, France), Amira Benjelloun, of Clinique Couer et Vaisseaux & Clinique AGDAL (Rabat, Morocco), and Qingsheng Lu, M.D. and Zaiping Jing, M.D., of Changhai Hospital (Shanghai, China), will present their experiences with the Cardiatis multilayer stent for aortic aneurysms in their respective countries. Sherif Sultan, M.D., FRCS, EBQS-VASC, and Niamh Hines, M.D. of University College Hospital (Galway, Ireland), and Thomas Larzon, M.D., of Örebro University Hospital (Örebro, Sweden) will focus their talks on the effects of the stent on reducing the size of the aneurysm sac and the possibility of rupture.
Against the backdrop of those presentations, the session concludes with Edward B. Diethrich, M.D., of the Arizona Heart Foundation (Phoenix, AZ) arguing for the proposition that the Cardiatis multilayer stent will work for the treatment of complex aortic aneurysms and Zvonimir Krajcer, M.D., FACC, of University of Texas Health Science Center (Houston, TX) and Piergiorgio Cao, M.D., FRCS of Azienda Ospedaliera San Camillo-Forlanini (Rome, Italy) take a skeptical view.