Lombard Medical has announced that on 28 June 2016 the first commercial use of its new IntelliFlex Low Profile (LP) Delivery System took place to implant the Aorfix Endovascular Stent Graft. The procedure was completed by Nilo J Mosquera, head of the Department of Angiology and Vascular Surgery, Complexo Hospitalario Universitario de Ourense, Spain.
The IntelliFlex LP Delivery System features a low profile, intuitive, compact and ergonomic design that enhances the precision and control of Aorfix deployment and placement. The system also incorporates an integrated exchange sheath to facilitate the delivery of ancillary devices during the endovascular abdominal aortic aneurysm (AAA) procedure. This feature avoids the need for catheter exchanges, potentially reducing procedure time, blood loss and vessel trauma. This new and innovative system will be used for the delivery of the Aorfix endovascular stent graft, the only AAA stent graft with global approval to treat aortic neck angulation up to 90 degrees. The company plans to begin shipments in July to its direct markets in the UK and Germany, and expects a full commercial launch in the other European markets later in the year.
“My surgical team and I were very pleased with the performance of IntelliFlex LP,” said Mosquera. “The device’s lower catheter profile was able to successfully navigate this particular patient’s calcified access vessels, something that in our experience might have not been possible with the previous generation’s delivery profile. The enhanced control of the new Y-mechanism is a significant improvement in stent delivery technology and provides greater control and precision when deploying the proximal end of the devices, allowing for a very precise graft placement. The integrated exchange sheath is also beneficial in reducing potential vessel trauma and facilitates the less invasive percutaneous approach.” Mosquera added that the new IntelliFlex delivery system is simple, intuitive, and easy to use.
“The user and procedure advantages of the IntelliFlex LP together with the outstanding long-term Aorfix clinical data will provide physicians with an even more compelling reason to use this technology to treat an even greater range of patient anatomies,” said CEO Simon Hubbert. “We believe our portfolio approach with our patient centred combination of Aorfix with IntelliFlex LP to treat complex anatomy and our new Altura stent graft which delivers multiple advantages for the treatment of patients with more routine AAA anatomy, will provide physicians with greater treatment options. We believe this product combination will be a significant driver of revenue growth in 2016 and beyond. We look forward to our European commercial launch of IntelliFlex in July.”