Cook Medical said that its Zenith TX2 TAA Endovascular Graft with Pro-Form to specifically to repair thoracic aortic aneurysms (TAAs) in anatomies with tight arches as well as conventional cases will improve thoracic endovascular repair (TEVAR) treatment.
Cook Medical said that Zenith graft, which received FDA approval in May 2009, provides an advanced treatment solution for a life-threatening condition that is diagnosed in 15,000 patients in the US each year.
TX2 with Pro-Form graft is designed to enhance treatment in patients whose tight aortic arches pose special difficulties for TEVAR but who cannot tolerate open surgical intervention.
TX2 with Pro-Form alleviates the need for complicated measures. Featuring an improved delivery system specifically engineered for patients with tight arches, Zenith TX2 with Pro-Form provides physicians with greater levels of control during endograft deployment to help establish proximal conformity of the device to the aortic wall. As a result, the device helps prevent the ‘bird’s beak’ gap that prevents proper sealing of the aneurysm, leading to more viable aneurysm repair and restored aortic blood flow.
Cook’s Zenith TX2 product line offers solutions for TAA patients who may not be candidates for treatment through open surgery because of its invasive nature. Zenith TX2 with Pro-Form also received approval from Health Canada in January 2010 and is currently available in the European Union, Russia, Israel, the United Arab Emirates, Australia, India, Chile and other markets.
Phil Nowell, global leader of Aortic Intervention business unit at Cook Medical, said: “Zenith TX2 with Pro-Form technology is a direct result of our collaboration with physicians who told us what they needed in order to expand treatment and improve outcomes for TAA patients. Cook is the first to address this particular challenge to TEVAR, and the response from the medical community is extremely positive.”
Benjamin Starnes, associate professor of surgery and chief of vascular surgery at the University of Washington in Seattle, said: “25% of patients with TAAs, mostly women, have narrow ‘gothic’ aortic arches. Zenith TX2 with Pro-Form expands the effectiveness of TEVAR within this large subset of patients and opens the door to future innovations that will address other anatomical challenges physicians frequently encounter in potential candidates for this treatment.
“With its ability to provide physicians with highly controlled device deployment, TX2 with Pro-Form helps ensure the endograft conforms to, and presses against, the aortic wall and repairs the aneurysm without the ‘bird’s beak’ effect seen in some earlier thoracic endografts.”