FDA approval for Zenith Dissection Endovascular System for the endovascular treatment of patients with Type B aortic dissection.- Cook Medical

Cook Medical announced its recent approval from the FDA for its Zenith Dissection Endovascular System. The system, consisting of a proximal stent-graft component and a distal bare stent component, provides physicians a less invasive alternative to open surgery for repair of Type B dissections of the descending thoracic aorta. The device will be available for sale in the U.S. in the coming months.

The delivery catheter containing the stent graft is inserted into a blood vessel (femoral artery) in the groin through a small incision and is carefully guided within this artery to the location in the aorta where the tear begins (entry tear). The stent graft is then released and self-expands to seal off the entry tear and make a new path for the blood to flow. If needed, the bare stent is then inserted and placed below the stent graft in a similar manner to gently reinforce and hold the layers of the aorta together.

Comment:The device offers physicians an alternative to open surgery for repairing Type B dissections of the lower thoracic aorta, an area of the aorta that is located in the thorax.