Lombard Medical’s portfolio of endovascular stent graft systems, Altura and Aorfix, were featured in scientific presentations at the 39th annual Charing Cross International Symposium (London, UK).
Combined Altura clinical data from two prospective international multicentre studies were presented at CX in a paper titled “A new low-profile device approach—results out to five years”, by Dainis Krievins (Riga, Latvia) on behalf of the study investigators.
Key findings of the 90-patient dataset were as follows:
- Technical success was 99%
- Percutaneous access was achieved in 57% of patients
- Only 21% of patients required general anaesthesia
- There were no abdominal aortic aneurysm (AAA)-related deaths over the period of follow-up
- No patients suffered sac expansion
- Mean follow-up of 12.4 months.
Krievins, commenting on the results, said, “Altura is impressively easy to use based on its 14F profile, repositionability and avoidance of cannulation. The performance of the stent graft, as demonstrated in the clinical data, is equivalent to contemporary grafts that do not share these advantages.”
In a second presentation about the clinical utility of Altura, Paul Hayes (Cambridge, UK) used a video case study to demonstrate the ease of use of the system. Hayes cited Altura’s unique retrograde limb deployment with built-in contrast injection in aiding predictable, shorter, procedure times.
Lombard is initiating a European registry for the CE marked Altura system which is now available commercially in the UK and certain other international markets.
Lombard Medical says that the Altura system represents a paradigm shift in endograft design offering a simple and predictable option for standard AAA anatomy. Delivered via an ultra-low profile 14F catheter, Altura allows for repositioning during deployment and accurate graft placement at each renal artery enabling physicians to utilise all of the available aortic neck. It also eliminates the need for cannulation that results in a simple, safe and consistent deployment with predictable, shorter procedure times. With just six product sizes, the Altura system allows the majority of patients to be treated quickly with minimal hospital stay and recovery times.
Also at CX, Andrew Holden (Auckland, New Zealand), in a video of an Aorfix case that involved a 90-degree neck, demonstrated the new IntelliFlex LP delivery system highlighting control and precision in placing the proximal part of the stent graft even in very challenging anatomies.
“The improvements provided by the IntelliFlex delivery system have made placing the Aorfix graft much more controlled, and it is now very user friendly. With the Y-Mec active opening feature, the built-in exchange sheath and haemostatic valve, it is now a device for routine use in the majority of EVAR patients, as well as its unique application in highly angulated and tortuous cases,” said Holden.
Lombard Medical notes that Aorfix is the only endovascular stent graft with global approvals to treat patients with severe aortic neck angles up to 90 degrees. The new, intuitive and low-profile IntelliFlex LP delivery system gives a high level of precision and control in treating this range of patient anatomies.