Cook Medical's Aortic Intervention Division Builds On Success With Innovative, New Minimally Invasive Treatments for Aortic Diseases.

Company's Patient-Focused Approach Drives Continuous Product Innovation And Global Sales Momentum

NEW YORK -- According to the Society for Vascular Surgery, approximately 200,000 people in the U.S. are diagnosed with an abdominal aortic aneurysm (AAA) each year, while another 15,000 cases of thoracic aortic aneurysms (TAA) are diagnosed annually. With an increasing aging population in which aortic disease occurs most commonly, Cook Medical continues to reinforce its unwavering commitment to delivering the industry's most innovative aortic disease treatment devices to significantly improve patient outcomes.

After years of sustained global leadership in the field of minimally invasive aortic disease treatment in the AAA market, and recently reaching a $1 million-per-month sales milestone in the U.S. TAA market with the launch of the Zenith TX2 Thoracic Aortic Aneurysm Endograft System, Cook Medical's Aortic Intervention strategic business unit continues to lead this segment in total market share. The announcement comes at the 35th annual VEITHsymposium, a five-day event featuring surgeons focused on the latest advances, concepts and controversies in vascular disease.

Already a market leader in the treatment of AAAs, the company has recently had two major landmarks with its advanced technologies in the treatment of aortic diseases. In August, Cook received U.S. Food and Drug Administration (FDA) approval to market its improved Zenith AAA Iliac Flex Legs, which provide significantly improved flexibility and conformability for its shorter lateral and contralateral stents.

"Our goal, simply put, is to relegate open repair of aortic aneurysms to the dustbin of history, much the same way keyhole gall bladder surgery supplanted open surgery. Cook's recent achievements in aortic intervention, and the unparalleled pipeline of advanced devices we have coming in the next few years, are a testament to our commitment to bringing to market the most innovative technologies for treating aortic diseases," said Phil Nowell, global leader of Cook Medical's Aortic Intervention strategic business unit. "We expect to see continued growth in both the AAA and TAA market, and to begin seeing Cook lead the way with the world's first disease-specific endografts for the treatment of aortic dissection, as we strive to bring the most advanced non-invasive options to each and every patient suffering from aortic disease."

As part of that effort, Cook recently submitted an Investigational Device Exemption (IDE) application to the FDA for its Zenith Fenestrated Abdominal Aortic Aneurysm Endovascular Graft, which is the first of its kind to incorporate custom-tailored openings in the top section of the endograft. This feature allows the graft to treat aortic and aortoiliac aneurysms extending close to the renal and superior mesenteric arteries. With IDE approval, Cook will initiate a U.S. clinical trial to evaluate the safety and effectiveness of the device, which is custom-manufactured at Cook's manufacturing facility in Australia to the precise anatomical needs of each individual patient's anatomy based on CT scans and other measurements, something no other medical device manufacturer can do.

Cook has also gained momentum in the TAA industry with its current offering, Zenith TX2 TAA Endovascular Graft, by reaching the $1 million-per-month mark in United States sales, with 75 U.S. physicians trained and 100 hospitals opened. Having only received FDA approval in May, this is a milestone showing Cook's move toward dominance in the TAA market. The Zenith TX2 is designed specifically to treat patients undergoing thoracic endovascular aortic repair (TEVAR) for descending thoracic aneurysms and ulcers. Similar to its sister AAA devices, Zenith TX2 offers a solution to those patients who may not have been suitable for treatment through open surgery due to its invasive nature.

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 minimally invasive medical 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. Founded in 1963 and operated as a family-held private corporation, 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 www.cookmedical.com.

About VEITHsymposium

Now in its fourth decade, VEITHsymposium provides vascular surgeons, interventional radiologists, interventional cardiologists and other vascular specialists with a unique and exciting format to learn the most current information about what is new and important in the treatment of vascular disease. The 5-day event features 350 rapid-fire presentations from world-renowned vascular specialists with emphasis on the latest advances, changing concepts in diagnosis and management, pressing controversies and new technique. VEITHsymposium is sponsored by Cleveland Clinic.