Updated on 21 May 2015
Lombard Medical Inc, a medical device company focused on Endovascular Aneurysm Repair (EVAR) of abdominal aortic aneurysms (AAA), announced that the first procedures were successfully performed in Japan using the Company's unique Aorfix Endovascular Stent Graft with the new AorFlex Delivery system.
The AorFlex Delivery system received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) in March, and provides controlled, easy delivery of Aorfix, the first and only endovascular stent graft with worldwide regulatory approvals for the treatment of patients with aortic neck angulations up to 90 degrees.
The first AorFlex cases in Japan were performed at ShinSapporo Hospital of Cardiology by Dr Yoshihiko Kurimoto, Director, Aortic Endovascular Therapeutic Center of Teine Hospital, and at Nara Medical University Hospital IVR Center, by Prof Kimihiko Kichikawa and Dr Shinichi Iwakoshi, Department of Radiology.
Dr Kurimoto stated, "Aorfix addresses unmet needs which we could not achieve with other devices, providing great benefit to my patients. The AorFlex delivery system allows for improved control, ensuring that I deploy the stent graft more accurately." Prof Kichikawa, Nara Hospital added, "AorFlex provides enhanced navigation in tortuous anatomies and allows precise deployment, especially in AAA patients with challenging anatomies. With AorFlex, I believe Aorfix will become a leading AAA device option in Japan."
Japan is the world's second largest standalone EVAR market; it was estimated at $140 million or 10 percent of the global market in 2013 and has been growing at an average rate of 18 percent over the last five years. There are approximately 400 physicians at 200 clinics performing EVAR in Japan, and it is estimated that around 55 percent of Japanese AAA patients are treated using this method.
Lombard Medical CEO Simon Hubbert commented, "The launch in Japan continues to gain great momentum thanks to the hard work of our exclusive distributor Medico's Hirata and the receptiveness of physicians in Japan who are using Aorfix to treat both simple and complex AAA anatomies. We are pleased with the initial results from the first procedures using the AorFlex delivery system and look forward to the continuing adoption of Aorfix in this important and growing market."