Lombard Medical has received approval from the Japanese Ministry of Health, Labour and Welfare for its IntelliFlex low profile (LP) delivery system for Aorfix endovascular stent graft.
The company plans to launch the system following reimbursement approval, which is expected in the next month.
Japanese vascular products supplier Medico's Hirata will exclusively distribute the Aorfix with IntelliFlex system in the country.
The new delivery system, which is used in conjunction with the Aorfix endovascular stent graft, is claimed to be the only AAA stent graft with global regulatory approval to treat aortic neck angulation up to 90 degrees.
IntelliFlex LP delivery system includes a low profile compact and ergonomic design that enables to control Aorfix during deployment.
It will also include an integrated exchange sheath that will enable ancillary devices to be introduced during the endovascular AAA procedure, helping to eliminate need for sheath exchanges for reducing blood loss, vessel trauma, procedure cost and time.
Aorfix is an endovascular stent graft system to treat infra-renal aortic and aorto-iliac aneurysms or abdominal aortic aneurysms.
It will create an internal bypass of the aneurysm to reduce the risk of rupture. Aorfix, which also has a CE mark, secured FDA approval in 2013.
Medico’s Hirata president Masataka Hirata said: “We have enjoyed great success already with Aorfix in Japan and built our market share to approximately 8% over the last two years.”
Lombard Medical CEO Simon Hubbert said: “Japan is the world’s second largest standalone EVAR market and is both strategically and financially important for us.”