Lombard Medical Technologies (NSDQ:EVAR) said today it won CE Mark approval in the European Union for its IntelliFlex low profile delivery system for its Aorfix endovascular stent graft.
The system is designed for the delivery of the company’s abdominal aortic aneurysm Aorfix endovascular stent graft, and includes an integrated exchange sheath designed for the delivery of ancillary devices during the procedure, the company said. The design removes the need for catheter exchanges, which Lombard said saves procedure time, blood loss and possible vessel trauma.
“The 1st-in-man procedure with the new IntelliFlex delivery system was extremely straightforward and the device was a real pleasure to use. I particularly appreciated the new Y-mechanism that enables greater control and precision when deploying the graft. This enhanced design is a significant advancement for the Aorfix system and the device can now be used even more reliably in both routine and challenging anatomies,” Dr. Andrew Holden of the Auckland University School of Medicine said in a press release.
Lombard said it plans to begin shipments of the device next month to the U.K. and Germany, with a full commercial launch slated for other European countries later in the year.
“The procedure advantages of the IntelliFlex LP together with the outstanding long-term clinical results of Aorfix will provide physicians with an even more compelling reason to use this technology to treat an even greater range of patient anatomies. We believe the combination of Aorfix with IntelliFlex LP and our new Altura stent graft which delivers multiple advantages for the treatment of patients with more routine AAA anatomy will be a significant driver of revenue growth in 2016 and beyond. We look forward to our European commercial launch of IntelliFlex in July,” CEO Simon Hubbert said in prepared remarks.
Last week, Lombard released 5-year results from the Pythagoras trial of its Aorfix, which aimed to evaluate the safety and effectiveness of the stent graft in treating highly angulated aortic necks or tortuous aortoiliac anatomy.
A presentation based on data from the study was presented at the 2016 Society for Vascular Surgery’s annual meeting in National Harbor, Maryland this week, the company said.
A total of 87% of surviving patients in the 218 patient trial were followed-up with at 5 years, Lombard said, with 60% of angled neck patients showing significant aneurysm sac shrinkage. Patients with low angle aortic necks reported similar outcomes, the company said.
All cause mortality, aneurysm-related mortality, secondary intervention and aneurysm rupture at 5 years were equivalent to reports from EVAR trials of patients with normal anatomy, the company said.
