Aorfix with IntelliFlex is exclusively distributed in Japan by Medico’s Hirata Inc., one of the country’s suppliers of vascular products with expertise in building significant market share for AAA stent grafts.
IntelliFlex is used in conjunction with the Aorfix endovascular stent graft, the only AAA stent graft with global regulatory approvals to treat aortic neck angulation up to 90 degrees. IntelliFlex is designed to be easy and intuitive to use, is low profile and compact, and incorporates numerous ergonomic features designed in collaboration with physicians.
“We have had good experience with the Aorfix stent graft and now following our initial cases with the new IntelliFlex delivery system, we are extremely impressed by the control and precision of placement with the new technology,” said Dr. Naoki Toya, consultant vascular surgeon at Tokyo Jikei University Kashiwa Hospital.
Japan is the world’s second largest standalone EVAR market, is estimated at 10 percent of the global market and has been growing at an average rate of approximately 18 percent. In Japan, there are approximately 400 physicians at 200 clinics performing EVAR and it is estimated that approximately 55 percent of Japanese AAA patients are treated using this method.1
“Gaining Japan regulatory approval for the IntelliFlex LP Delivery System has been a primary strategic goal for the company. With that in hand, we are excited by the potential for growth in our business in Japan for the Aorfix stent graft now paired with IntelliFlex and its significant advantages,” said Lombard Medical CEO Simon Hubbert. “We continue to innovate and expand the capabilities of our core technologies in key global markets and look forward to seeing the benefits of IntelliFlex reflected from our customers’ experience and patient outcomes.”
Aorfix is an endovascular stent graft system for treating infra-renal aortic and aorto-iliac aneurysms, also known as abdominal aortic aneurysms. When placed within the aneurysm, Aorfix creates an internal bypass of the aneurysm to reduce the risk of rupture. Aorfix is the first and only endovascular stent graft with global approvals for the treatment of patients with aortic neck angulations up to 90 degrees. Aorfix features an exclusive helical and circular design that allows it to conform to the natural contours of human anatomy, including aortic necks with high angulations and iliac arteries with extreme bends. Aorfix has been evaluated in three studies and used in more than 7,000 procedures worldwide. Aorfix has a CE Mark, Japan regulatory approval, and received U.S. Food and Drug Administration approval in 2013.
About Abdominal Aortic Aneurysms 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 more than 500,000 new cases are diagnosed. In the United States, aortic aneurysm disease is among the leading causes of death and it is estimated that 1.5 million people have an abdominal aortic aneurysm.
Lombard Medical Inc. is an Oxfordshire, United Kingdom-based medical device company focused on the $1.8 billion market for minimally invasive treatment of abdominal aortic aneurysms. The company has global regulatory approval for Aorfix, an endovascular stent graft that has been specifically designed to treat patients with the broadest range of AAA anatomies, including aortic neck angulation up to 90 degrees. The company has also achieved CE Mark for the Altura endograft system, an ultra-low profile endovascular stent graft that offers a simple and predictable solution for the treatment of more standard AAA anatomies.
1. Medtech Ventures: Aortic Intervention Market (2014)