Following the recent US Food and Drug Administration (FDA) approval of Cook Medical’s Zenith Dissection Endovascular System, Cooper University Health Care in Camden, USA, has treated the first patient in the US with the device as part of Cook’s US commercial launch.
“We are committed to helping patients by developing a variety of treatment options for aortic disease,” said Mark Breedlove, vice president of Cook Medical’s Vascular division. “We are pleased to provide US clinicians and patients another minimally invasive option for aortic repair.”
The system provides physicians a less invasive alternative to open surgery for repair of Type B dissections of the descending thoracic aorta. It consists of a proximal stent-graft component and a distal bare stent component.
“The value in this dissection stent is that it is pathology-specific, designed just for this disease,” said Joseph Lombardi, director of the Cooper Aortic Center. “As the principal investigator, receiving FDA approval is something that I had really looked forward to. It is really exciting and I think it is going to make a big impact on how dissection is managed.”
Aortic dissection is a tear that occurs between the innermost and middle layers of the aorta. When the inner layer of the aorta tears, blood flows through the tear, which causes the inner and middle layers of the aorta to separate (dissect). Type B dissection involves a tear in the descending aorta.
Globally, thoracic endovascular aortic repair (TEVAR) is acknowledged as the treatment of choice for complicated Type B aortic dissection. These procedures are meant to prevent malperfusion of aortic branches and aortic rupture.