Noticias

Noticias

  • Título: First Post Approval Cases with Aorfix™ Performed in Japan
  • Fecha: 02-09-2014

  • Lombard Medical Launches Device inSecond Largest Standalone

    Endovascular Aneurysm RepairMarket Through Exclusive Distribution Partner Medico’s Hirata

    Irvine,CA and London, UK – September 2, 2014 – Lombard Medical, Inc. (NASDAQ: EVAR), a medical device company focused on Endovascular Aneurysm Repair (EVAR) of abdominal aortic aneurysms (AAA), today announced that the first two post approval procedures using Lombard Medical’s flagship Aorfix™endovascular 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 stand alone EVAR market; it is estimated at $140million 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 estimatedthat around 55 percent of Japanese AAA patients are treated using this method.1

    The first two cases in Japan were performed at Tokyo Jikei Medical University by Prof. Takao Ohki, and at Morinomiya Hospital (Osaka) by Prof. Masaaki Kato. Takao Ohki, M.D., Ph.D., Professor and Chief, Department of Vascular Surgery at Tokyo Jikei Medical University, stated, “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, M.D., Ph.D., Chief, Departmentof Cardiovascular Surgery at Morinomiya Hospital, added, “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 CEO Simon Hubbert commented, “Leading physicians and our distribution partner have been working diligently towards the opportunity to begin usingAorfix 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 growingmarket.”

    Lombard Medical’s distribution partner, Medico's Hirata Inc., debuted the Aorfix graftlast week at the Japan Endovascular Symposium (JES) in Tokyo, where Dr. Nilo Mosquera (Ourense, Spain) presented the combined European experience of Aorfix incomplex anatomy to a highly engaged crowd of attendees. Dr. Mosquera statedthat “Aorfix is my go-to graft for infrarenal aneurysms because of its uniqueability to navigate and conform to tortuous iliacs,” and reported that he successfully performs the majority of his cases percutaneously.

    LombardMedical will continue to support the launch of Aorfix to the Japanese market this week with a featured workshop, and podium presentation at the 15th Asian Society for Vascular Surgery congress Sept. 5-7 in Hong Kong. Further cases are scheduled in Japan over the next several weeks.

    About Abdominal Aortic Aneurysms (AAAs)

    AAAs are balloon-like enlargements of the aorta which, if left untreated, may rupture and cause death. Approximately 4.5 million people are living with AAAs in the developed world and each year over 500,000 new cases are diagnosed. In the US, aortic aneurysm disease is among the leading causes of death and it is estimated that 1.5 million people have an abdominal aortic aneurysm.

    About Medico's Hirata

    Founded in 1918 and headquartered in Osaka, Medico's Hirata Inc. is a leading supplier and developer of medical device products for the Japanese healthcare industry. With more than 100 devices approved, the Company has built up extensive industry experience and a thorough understanding of the regulatory landscape in Japan. In 2006 the Company received regulatory approval to launch aortic stent grafts for the treatment of abdominal aortic aneurysms, complementing its broad portfolio of minimally invasive, innovative devices in the field of vascular intervention.

    Furtherbackground on the Company can be found at http://www.medicos-hirata.co.jp/english/.

    Prof. Ohky and the rest of the team with Dr. Nilo Mosquera (Spain)




  • Fuente: endovascular.es