Lombard Medical Receives Japanese Regulatory Approval for IntelliFlex LP Delivery System

Lombard Medical Inc., developer of endovascular aneurysm repair (EVAR) technology for abdominal aortic aneurysms (AAAs), has received approval from the Japanese Ministry of Health, Labour and Welfare for its IntelliFlex Low Profile (LP) Delivery System for the Aorfix Endovascular Stent Graft. Commercial launch will follow reimbursement approval, which is anticipated in February 2017.
 
Aorfix with IntelliFlex is exclusively distributed by Medico’s Hirata Inc., one of Japan’s leading suppliers of vascular products with proven expertise in building significant market share for AAA stent grafts.
 
This new delivery system is used in conjunction with the Aorfix endovascular stent graft, the only AAA stent graft with global regulatory approval to treat aortic neck angulation up to 90 degrees. 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 endovascular AAA procedure avoiding the need for sheath exchanges thus potentially reducing blood loss, vessel trauma, procedure cost and time.

“We have enjoyed great success already with Aorfix in Japan and built our market share to approximately 8 percent over the last two years,” said Masataka Hirata, president of Medico’s Hirata Inc. Now with the approval of IntelliFlex, we believe we will significantly increase the usage of this unique technology for the benefit of physician’s ease of use, procedural outcomes and patients across the broadest range of AAA anatomies.”

Aorfix is an endovascular stent graft system for treating infra-renal aortic and aorto-iliac aneurysms, also known as abdominal aortic aneurysms (AAAs). 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.
 
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 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.
 
“Japan is the world’s second largest standalone EVAR market and is both strategically and financially important for us,” said Lombard Medical CEO Simon Hubbert. “With our partner, Medico’s Hirata, we look forward to providing Japanese physicians with the Aorfix stent graft, which has outstanding clinical results, now delivered with the unique advantages of the IntelliFlex LP Delivery System.”
 
The EVAR market in Japan 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
 
Business Update
The Company is reporting preliminary revenue of $2.4 million for the 2016 fourth quarter and $12.1 million for the 2016 full year as compared to the most recent guidance provided in August 2016 which reflected a revenue floor of $13 million. Underlying this shortfall is the company’s previously stated strategy to exit the U.S. market and to pursue cash conservation measures to bridge the business to the recently announced transaction with MicroPort Scientific Corporation.
 
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 (AAAs). 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 innovative ultra-low profile endovascular stent graft that offers a simple and predictable solution for the treatment of more standard AAA anatomies.

Reference:
1. Medtech Ventures: Aortic Intervention Market (2014)