Cook Medical has launched its Zenith dissection endovascular system, recently approved by the FDA.
The first patient was treated with the system at Cooper University Health Care in Camden, N.J., Cook Medical announced yesterday.
The Zenith system was designed to provide physicians with a less-invasive alternative to open surgery for repair of Type B dissections of the descending thoracic aorta. Zenith consists of a proximal stent-graft component and a distal bare-stent component.
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.
“We are committed to helping patients by developing a variety of treatment options for aortic disease,” said Mark Breedlove, VP of Cook Medical’s Vascular division, in a prepared statement. “We’re pleased to provide U.S. clinicians and patients another minimally invasive option for aortic repair.”
“The value in this dissection stent is that it’s pathology-specific, designed just for this disease,” added Dr. Joseph Lombardi, director of the Cooper Aortic Center and principal investigator for two clinical trials of the device. “Receiving FDA approval is something that I had really looked forward to. It’s really exciting and I think it’s going to make a big impact on how dissection is managed.”