Lombard Medical has announced that it has expanded the European launch of its new Altura endovascular stent graft system to The Netherlands and Spain.
On 4 July 2016, Clark J Zeebregts, Paul M van Schaik and Ignace F Tielliu, all consultant vascular surgeons, successfully completed three Altura procedures at the University Medical Center Groningen in The Netherlands. In addition, on 30 June 2016, Nilo J Mosquera, head of the Department of Angiology and Surgery, Complexo Hospitalario Universitario, successfully completed the first Altura procedure in Ourense, Spain.
“After successfully completing three Altura procedures in one day, we found the device to be intuitive and simple to use. The removal of the cannulation step required for other systems is a nice feature that will enable us to predict consistent procedure times and ultimately reduce physician and patient X-ray exposure,” said Zeebregts.
Van Schaik added, “We have a large and diverse EVAR practice, and we can see Altura becoming our ‘go to’ endovascular stent graft as we gain more clinical experience over the coming months.”
“We are honoured to be the first centre in Spain to complete an Altura EVAR procedure,” said Mosquera. “We found the new Altura stent graft easy to use, with a minimal amount of steps required to implant the stent graft. We were especially impressed with the 14F ultra-low profile design and the elimination of the gate cannulation step which can be a real procedural time saver.”
“We have been very encouraged by our momentum since launching Altura in the UK and Germany in late February, and we are delighted to be expanding the rollout into The Netherlands and Spain,” said CEO Simon Hubbert. “We believe our new Altura stent graft delivers multiple advantages for the treatment of patients with more routine abdominal aortic aneurysm anatomy, and we look forward to further expansion of the Altura launch throughout Europe in the weeks and months to come.”
According to Lombard Medical, the Altura system represents a paradigm shift in endograft design that offers a simple and predictable treatment option for standard abdominal aortic aneurysm 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 who present for EVAR repair to be treated quickly with minimal hospital stay and recovery times.
The Altura system received the CE mark in 2015. Lombard launched the device in the UK and Germany in February 2016 with a broader international rollout currently underway. In the USA, Lombard intends to file for an IDE (investigational device exemption) from the FDA in the summer of 2016 with the intent to begin recruitment for a US clinical study in H1 2017.