Healthcare Industry News:  Cook Medical  

Devices Interventional

 News Release - April 13, 2010

Global Adoption of Cook Medical's Advanced TEVAR Technology Reflects Physician Support for New Conformable Stent-Graft

BLOOMINGTON, Ind.--(HSMN NewsFeed)--Physicians have treated more than 1,250 patients worldwide with the Zenith® TX2™ TAA Endovascular Graft with Pro-Form™, the first-of-its-kind device from Cook Medical designed specifically to repair thoracic aortic aneurysms (TAAs) in anatomies with tight arches as well as conventional cases. Cook’s new 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 U.S. each year1. Physicians say they are embracing TX2 with Pro-Form because the graft is designed to enhance treatment in patients whose tight aortic arches pose special difficulties for thoracic endovascular repair (TEVAR) but who cannot tolerate open surgical intervention.

“Twenty five percent of patients with TAAs, mostly women, have narrow ‘gothic’ aortic arches,” said Benjamin Starnes, M.D., associate professor of surgery and chief of vascular surgery at the University of Washington in Seattle. “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.”

TAAs occur when a section of the aorta weakens and bulges outward, creating a risk of severe internal bleeding. Only 20 to 30 percent of patients who arrive at the hospital with a ruptured TAA survive2. Unfortunately, many endografts are too rigid or possess sealing stents that lack the radial force to conform correctly to the inner curvature of tight aortic arches. Surgeons must therefore remodel the arch with a balloon or other aids to reduce the risk of continued bleeding and possible rupture.

TX2 with Pro-Form is designed to alleviate the need for such 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.

“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,” said Phil Nowell, global leader of Cook Medical’s Aortic Intervention business unit. “Cook is the first to address this particular challenge to TEVAR, and the response from the medical community is extremely positive.”

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.

About Cook Medical

Founded in 1963, Cook Medical pioneered many of the medical devices now commonly used to perform minimally invasive medical procedures throughout the body. Today, the company integrates medical devices, drugs and biologics to enhance patient safety and improve clinical outcomes. Since its inception, Cook has operated as a family-held private corporation.

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1 , 2 Thoracic Aortic Aneurysm.VascularWeb. 2009. Available at: Accessed February 11, 2010.

Source: Cook Medical

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