Lombard Medical has announced that the first two post approval procedures using the Aorfixendovascular stent graft were performed in Japan. Aorfix received approval from the Japanese Ministry of Health, Labour and Welfare in August, and is the first and only endovascular stent graft with worldwide regulatory approvals for the treatment of patients with aortic neck angulations up to 90 degrees.
Japan is the world’s second largest standalone EVAR market; it is estimated at US$140 million or 10% of the global market in 2013 and has been growing at an average rate of 18% over the last five years. There are approximately 400 physicians at 200 clinics performing EVAR in Japan, and it is estimated that around 55% of Japanese AAA patients are treated using this method.
The first two cases in Japan were performed at Tokyo Jikei Medical University by Takao Ohki, and at Morinomiya Hospital (Osaka) by Masaaki Kato. Takao Ohki, professor and chief, Department of Vascular Surgery at Tokyo Jikei Medical University, states, “I am pleased that Aorfix can address unmet needs which could not be achievable with other devices, and this device will surely be of great benefit to patients.” Masaaki Kato, chief, Department of Cardiovascular Surgery at Morinomiya Hospital, adds, “Aorfix is a novel, easy-to-use device that performs well in anatomies where standard devices could struggle. I believe
Aorfix could become a leading AAA device option in Japan.”
Lombard Medical chief executive officer Simon Hubbert comments, “Leading physicians and our distribution partner have been working diligently towards the opportunity to begin using Aorfix in Japan. That enthusiasm has translated into strong initial interest and the first clinical procedures within a month of approval. We are pleased with this initial positive response and look forward to the continued adoption of Aorfix in this important and growing market.”
Lombard Medical’s distribution partner, Medico’s Hirata, debuted the Aorfix graft last week at the Japan Endovascular Symposium (JES) in Tokyo, where Nilo Mosquera (Ourense, Spain) presented the combined European experience of Aorfix in complex anatomy to a highly engaged crowd of attendees. Mosquera states that “Aorfix is my go-to graft for infrarenal aneurysms because of its unique ability to navigate and conform to tortuous iliacs,” and reported that he successfully performs the majority of his cases percutaneously.