Healthcare Industry News:  Cook Zenith 

Devices Interventional FDA

 News Release - May 23, 2008

Cook Medical Receives FDA Approval for Advanced Thoracic Aortic Aneurysm Endovascular Graft

Company's Zenith TX2(R) Thoracic Aortic Aneurysm Endovascular Graft Provides a Minimally Invasive Treatment for More Thoracic Aortic Aneurysm Patients

BLOOMINGTON, Ind.--(HSMN NewsFeed)--In a move that dramatically expands Cook Medical’s already industry-leading portfolio of advanced devices to treat aortic diseases, company officials announced Cook has received approval from the U.S. Food and Drug Administration (FDA) for its Zenith TX2 Thoracic TAA Endovascular Graft. The state-of-the-art aortic endograft is designed for thoracic endovascular aortic repair (TEVAR), a minimally invasive alternative to traditional, open surgery. The Zenith TX2 is indicated to treat patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair.

With FDA approval of the Zenith TX2, U.S. physicians can now provide an endovascular solution from Cook for the interventional treatment of thoracic aortic aneurysms (TAA), including patients who may not be eligible for treatment through open surgery. To demonstrate the benefits of the device, Cook sponsored the STARZ-TX2 clinical trial, a multi-national trial designed to study the safety and effectiveness of the Cook Zenith TX2. The trial results indicated that the TEVAR procedure, using Cook Medical’s Zenith TX2, is a safe and effective alternative to open surgical repair for the treatment of TAAs in patients with suitable anatomy.

“We are thrilled to reach this important milestone and introduce in the United States the Zenith TX2 which is uniquely designed to treat a broad range of patients suffering from TAA,” said Phil Nowell, global director of Cook’s Aortic Intervention strategic business unit. “The positive, 12-month clinical data serves as a proof-point that the TEVAR procedure, in conjunction with the Zenith TX2, has the potential to revolutionize the way thousands of TAA patients worldwide receive treatment. The recent FDA approval demonstrates Cook’s continued dedication to delivering unparalleled treatment options designed to meet physician and patient needs for safety, reliability and better outcomes."

TAAs occur when a section of the thoracic aorta weakens and bulges outward like a balloon. Ruptured aneurysms have a very high mortality rate, especially for TAA. The Cook Zenith TX2, a self-expanding tube of surgical graft material reinforced with metal stent bodies is sized to the diameter of the aorta and is used to seal off the aneurysm. The Cook Zenith TX2, which includes a unique uncovered distal stent with fixation barbs to hold the device in place, helps to relieve pressure on the aneurysm and reduce the risk of rupture and in most cases, allow the aneurysmal sac to shrink.

The Zenith TX2 device is deployed from a catheter inserted through a small incision in the patient’s femoral artery. This treatment is far less invasive than traditional, open surgery where physicians open patients’ chests, clamp off and remove the diseased section of the aorta and replace it with a surgical graft. Post-operative and post-discharge recovery times are typically much shorter with TEVAR, which may help patients return to their normal lifestyle routines faster than for those who undergo open surgery. Patients undergoing TEVAR also typically are at lower risk of the comorbidities associated with open surgical repair.

Cook’s Aortic Intervention strategic business unit has experienced significant growth throughout the past year. For the year-to-date, the business unit has increased its global sales by 28 percent. As Cook’s current offerings in aortic intervention continue to gain momentum and new products are introduced to market, this growth pattern is expected to continue through the year.


The Cook Zenith® TX2® Thoracic Aortic Aneurysm Endovascular Graft with the H&LB One-Shot™ Introduction System is available in many major markets throughout the world, including the United States, Europe, Canada and Australia.

About Cook Medical

Cook Medical was one of the first companies to help popularize interventional medicine, pioneering many of the devices now commonly used worldwide to perform minimally invasive medical procedures. Today, the company integrates device design, biopharma, gene and cell therapy and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; interventional cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Cook is a past winner of the prestigious Medical Device Manufacturer of the Year Award from Medical Device & Diagnostic Industry magazine. For more information, visit

Source: Cook Medical

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