Cook Medical said today that it won FDA approval for its Zenith Dissection endovascular system intended to treat Type B aortic dissections.
The Bloomington, Ind.-based company’s newly cleared system consists of a proximal stent-graft component and bare stent distal component and is intended to prove a less invasive alternative to open surgery for repairing Type B dissections of the descending thoracic aorta.
“We’re pleased to provide another minimally invasive option for aortic repair. The approval of this product gives us an opportunity to have a positive impact on the lives of patients with aortic dissections. Cook Medical is committed to developing a variety of treatment options for aortic disease –from the arch to the iliacs, in order to help physicians fit a device to each patient’s unique disease state,” Cook Medical vascular division VP Mark Breedlove said in a press release.
Cook Medical said that it plans to launch the device in the U.S. in the coming months.
Last month, Cook Medical said that it inked a deal to buy a former cigarette manufacturing plant in North Carolina.