Cook Medical announced on 2 March 2011 European availability of its Zenith Dissection Endovascular System, the first system engineered specifically for treating aortic dissection.
Zenith Dissection Endovascular System was evaluated in the STABLE clinical trial, with 40 procedures carried out at 10 sites across Europe, Australia and the United States. The CE marked system is the first to be commercially approved specifically for minimally invasive treatment of type B aortic dissections affecting the descending aorta.
Utilising a component approach, the system includes the Zenith Dissection bare metal stent, a unique disease-specific design that supports the delaminated section of the aorta while preserving access to the visceral branches. The bare metal stent is available in a range of lengths, with a standard diameter for all patients. The dissection system also seals off the primary entry tear with the Zenith TX2 TAA Endovascular Graft with Pro-Form.
“The Zenith Dissection Endovascular System is the first to offer a disease-specific minimally invasive treatment option for type B dissections. We are currently collating longer-term data and are hopeful that the device – in giving physicians more choice – will help to improve clinical outcomes for patients suffering with aortic dissection,” said Stephan Haulon, chief of vascular surgery at the Centre Hospitalier Régional Universitaire de Lille, France.
The system is an alternative to traditional medical management or the use of stent grafts alone; its ‘seal-and-stent’ approach encourages false lumen stasis and thrombosis as well as branch vessel reperfusion. The system also assists remodeling of the aorta by providing support to the delaminated section; it terminates false lumen patency and discourages aneurismal progression.