OXFORDSHIRE, United Kingdom, Nov. 21, 2016 (GLOBE NEWSWIRE) -- Lombard Medical, Inc., a medical device company focused on endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs), today announced that its Altura endovascular stent graft system was featured in a scientific presentation at the 43rdannual VEITHsymposium in New York City on November 17, 2016. The Altura stent graft, which was launched commercially in Europe earlier in 2016, is specifically designed to simplify treatment in patients with normal AAA anatomy.
The Altura stent graft was featured in a scientific presentation by Mr. David Murray, Consultant Vascular Surgeon at Manchester Royal Infirmary, Manchester, UK, titled, “Advantages and Limitations of Lombard’s Altura Endograft Device to Simplify EVAR Procedures: A Multicenter Study.”
The data showed a total of 24 patients were treated electively between April and October 2016. Sixteen patients were male, with a mean age of 75. Median AAA diameter was 60mm (52-105mm), median neck length was 23mm (15-60mm), median proximal neck diameter was 23mm (19-26mm), median β neck angulation was 31°. Median iliac landing zone diameter was 14mm (9-18mm). Access was percutaneous in 25 of 38 groins.
- 18 (75%) of patients were discharged at or before 24 hours (Day-Case EVAR).
- There were no deaths within 90 days.
- There were no immediate or delayed access-related complications.
Screening times and radiation doses were low and show a reduction over time and experience with the device:
- Deployment time ranged 19-45 minutes.
- Mean contrast dose was 150ml.
- Median intraoperative contrast dose was 75ml of 50% concentrate Visipaque 270.
- A further 60ml for rotational angiography at completion in the hybrid lab.
Technical success was 100% with freedom from type I/III endoleaks at 100% with stable aneurysm size and no evidence of stent-graft migration.
Mr. Murray commented, “The significance of the low contrast doses, low screen and procedure times and radiation dose reduction, already demonstrates some of the key benefits the new Altura system offers, even taking into account that this data includes the learning curve across two units. It has the potential to be a game-changer for EVAR as we have already been able to perform two-thirds of our Altura cases as ‘day-case’ procedures.”
Mr. Steve Richardson, Consultant Vascular Surgeon at University Hospital South Manchester (UHSM), UK, added, “We are extremely pleased with our early experience using Altura, the learning curve is rapid and it has quickly become the ‘go to’ endograft in our vascular unit.”
Lombard Medical CEO Simon Hubbert commented, “Altura clearly offers unique benefits to physicians and patients and significantly enhances the treatment of patients with standard AAA anatomy. Its unique features including an ultra-low profile 14F delivery system, the elimination of the unpredictable procedure step of ‘stent graft gate cannulation’ and retrograde iliac deployment all add up to a simpler, quicker, predictable and safer procedure with optimum outcomes.”