Lombard Medical Launches IntelliFlex LP Delivery System for Aorfix EVAR Device in Japan
September 26, 2017—Lombard Medical, Inc. announced the full commercial launch in Japan of its new low-profile IntelliFlex LP delivery system for the Aorfix abdominal aortic aneurysm endovascular repair stent graft device. The new delivery system is exclusively marketed in Japan by Osaka-based Medico’s Hirata, Inc.
The company advised that clinical cases confirming the performance and ease-of-use of the IntelliFlex LP delivery catheter in complex aortic aneurysm anatomies were presented by Makoto Sumi, MD, at the 12th Annual Japanese Endovascular Symposium in August 2017.
As noted in the company’s press release, early data from JANIS, the Medico-sponsored Japanese clinical study, were recently presented at the Japanese Society for Vascular Surgery and independently confirmed the data in the PYTHAGORAS United States clinical study that supported Lombard’s US Food and Drug Administration approval of the device.
The 5-year PYTHAGORAS data were presented in November 2016 by Prof. Mahmoud Malas, MD, at the 43rd annual VEITHsymposium in New York, New York. In July 2017, the data were published by Edward A. McGillicuddy, MD, et al in Journal of Vascular Surgery (2017;66:71–78).