Tokyo, Japan, October 7, 2009 — After three years of successful use as the first approved stent graft for endovascular aortic repair (EVAR), Cook Japan has announced that it will prepare an application for the PMDA's re-examination of its Zenith AAA Endovascular as required under article 14-4-1-1 of the Pharmaceutical Affairs Act. Approximately 3,000 Japanese patients have been treated with Cook's Zenith AAA stent graft, making it the top selling stent graft in Japan since being approved on July 11, 2006 under Japanese regulation 14-1 (approval number 21800BZY10175000).

The option of endovascular aneurysm treatment is determined by factors such as the overall health of the patient and their ability to withstand the demands of open surgery. Compared to more invasive surgical repairs, stent graft placement for AAA requires two small incisions in the groin area, and does not require a general anesthetic in many cases, thereby reducing the burden on patients. Furthermore, patients treated using EVAR can leave hospital within a week, while patients treated with open surgery must stay in hospital for three to four weeks. Due to this, stent graft surgery is becoming popular as a means of treatment that can improve patient quality of life (QOL).

“Stent graft for EVAR is an effective procedure for patients who cannot have open surgery because of their medical condition and age. In Japan, due to its aging society, we expect to cover more patients in the future via this procedure.” said Dr. Kimihiko Kichikawa, professor, department of radiology, Nara Medical University.

“There are some epoch-making inventions in medical history, like penicillin or coronary bypass repair. We can say EVAR is one of those inventions, because of its high safety and minimal invasiveness in comparison to open surgery. July 11, 2006 is the day we started to use stent grafts, so it's quite important. We have treated over 500 cases using EVAR in three years at Jikei University, and of those, we haven't had any mortalities caused by the surgery. It is a wonderful result that is unlikely with open surgery.” said Dr. Takao Ohki, chairman of the department of surgery, professor and chief of the department of vascular surgery at Jikei University.

Dr. Shin Ishimaru, executive director of the Japanese Committee for Stentgraft Management (JCSM) and assistant director of Toda Chuo General Hospital said, “Patients treated with a stent graft typically spend less time in hospital and can usually return to normal activities much sooner than open surgery patients. The treatment is conducted by experienced doctors who have successfully passed the examination to practice and the number is expected to rise. I would like patients who are suffering from an aortic aneurysm to deepen their understandings of its treatment, using information on the JCSM Web site.”

As a result of these benefits, use of EVAR has grown dramatically in Japan over the last three years. The Zenith AAA Endovascular Graft has been used in about 3,000 AAA procedures in Japan, and treatment using the device has increased significantly in this year. The company is currently working to obtain approval in Japan for a more advanced version of the Zenith AAA stent graft, for thoracic aneurysms, and other advanced technology EVAR products.

“With three years of outstanding clinical use of the Zenith AAA stent graft by Japan's leading physicians, Cook Japan looks forward to continuing to bring our most advanced endovascular technologies to the market,” said Glenn Ostlund, representative director of Cook Japan. “I am glad that Cook has been able to contribute to the successful treatment of Japanese AAA patients over the past three years since Zenith gained approval. We seek to further improve patient outcomes through the PMDA's necessary and routine re-examination of the device's approval by confirming Zenith's performance history to date.”

“Zenith was approved as the first aortic aneurysm stent graft with the support from doctors and medical facilities that participated in the clinical trials. As a three-year milestone for the use of Zenith and its re-examination, results from the PMS study will lead to the improvement of medical performance,” said Katsuji Takada, a senior regulatory science advisor who worked on the clinical trials and submission of application in Japan.

“As the first device of its kind approved here and a technological leader worldwide, Zenith has contributed to the advancement of AAA endovascular treatment in Japan. Cook Japan will continue to expand treatment solutions and provide patients and doctors with detailed information and supportive service,” said Naoyuki Yamaguchi, manager of Aortic Intervention business units that controls the distribution of Zenith products in Japan.

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 www.cookmedical.com. You may sign up to follow Cook Medical on Twitter at http.www.twitter.com/cookmedicalpr.