Lombard Medical wins CE Mark for Aorfix AAA stent graft delivery device

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 ...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Regulatory/Compliance Stent Grafts Vascular Lombard Medical Technologies Source Type: news