Lombard Medical Technologies (NSDQ:EVAR) said today it expanded the European launch of its Altura endovascular stent graft to the Netherlands and Spain, touting 4 completed procedures with the device in the newly expanded regions.
The Altura endograft system is designed as a transcatheter treatment for abdominal aortic aneurysms, and can be repositioned during deployment to allow for the utilization of the available aortic neck, the company said.
“We’ve been very encouraged by our momentum since launching Altura in the UK and Germany in late February, and we’re delighted to be expanding the rollout into the Netherlands and Spain. We believe our new Altura stent graft delivers multiple advantage,” CEO Simon Hubbert said in a press release.
Three procedures with the Altura stent graft system were performed at The Netherlands’ University Medical Center Groningen by Clark Zeebregts, Dr. Paul van Schaik and Dr. Ignace Tilliu, and a single procedure was performed at Spain’s Complexi Hospitalario Universitario by Dr. Nilo Mosquera.
“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,” Zeebregts said in prepared remarks.
“We are honored to be the first center in Spain to complete an Altura EVAR procedure. 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,” Dr. Mosquera said in a prepared statement.
Lombard picked up the rights to the Altura stent when it bought its initial developer, Altura Medical, last July.
The terms of the transaction between Irvine, Calif.-based Lombard and Silicon Valley-based Altura medical included the issuance of $15 million of Lombard stock at $4 per share, the assumption of $5.5 million in debt and $2.5 million in liabilities and transaction related costs, Lombard said.
The endograft system won CE Mark approval in the European Union last year. Lombard said it planned to file for investigational device exemption from the FDA this year and that it would begin recruitment for a clinical study the same year.
