Lombard Medical's IntelliFlex LP Delivery System for the Aorfix EVAR System Approved in Japan
January 5, 2017—Lombard Medical, Inc. announced approval from the Japanese Ministry of Health, Labor, and Welfare for its IntelliFlex LP low-profile delivery system for use with the Aorfix endovascular stent graft, which is used for endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms. The commercial launch in Japan will follow reimbursement approval, which is anticipated in February 2017. In Japan, Aorfix with IntelliFlex is exclusively distributed by Medico's Hirata Inc.
According to Lombard Medical, the IntelliFlex LP delivery system features a low-profile, compact, and ergonomic design that provides intuitive control of Aorfix during deployment, even in challenging anatomy. The system features an integrated exchange sheath allowing ancillary devices to be introduced during the EVAR procedure, avoiding the need for sheath exchanges, thus potentially reducing blood loss, vessel trauma, procedure cost, and time.
The Aorfix endovascular stent graft system is designed to treat infrarenal aortic and aortoiliac aneurysms. Aorfix has global approvals for the treatment of patients with aortic neck angulations up to 90º, advised Lombard Medical.