Lombard Medical Technologies (NSDQ:EVAR) said today it won approval from the Japanese Ministry of Health, Labour and Welfare for its Intelliflex low profile delivery system for the Aorfix endovascular stent graft.
The Oxfordshire, England-based company said it will initiate a commercial launch of the device in Japan once it receives reimbursement approval, expected some time next month. Currently, Medico’s Hirata has exclusive distribution rights to the Aorfix.
“We have enjoyed great success already with Aorfix in Japan and built our market share to approximately 8% over the last two years. 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,” Medico’s Hirata prez Masataka Hirata said in prepared remarks.
The newly cleared delivery system is designed to allow for more intuitive control of the Aorfix during deployment, Lombard Medical said, and features an integrated exchange sheath to allow ancillary devices to be introduced mid-procedure.
“Japan is the world’s second largest standalone EVAR market and is both strategically and financially important for us. 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,” Lombard Medical CEO Simon Hubbert said in a prepared statement.
Through the partnership, Lombard will seek to accelerate commercialization of its Arofix and Altura stent grafts for treating abdominal aortic aneurysms. Microport will gain exclusive marketing rights for both products in China and Brazil, as well as a license to manufacture the products for the Chinese market.