Lombard Medical Expands European Launch of Altura EVAR Device

June 8, 2016—Lombard Medical, Inc. announced updates on the controlled launch in Europe of the Altura endovascular stent graft system, which received European CE Mark approval for the endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs) in 2015. 

The company began the European launch of Altura in January, with initial commercial procedures in Germany and the United Kingdom. A broader European launch is planned for Q3 of 2016, with cases scheduled in Italy and Spain. Long-term clinical data with up to 4-year patient follow-up are planned to be released in the second half of 2016.

According to Lombard Medical, EVAR procedures using the Altura device have now been completed in 27 centers, and procedures are planned in an additional 10 centers in the coming weeks in the United Kingdom and Germany. Four Altura physician-training workshops were completed in Riga, Latvia, with future workshops scheduled in June and July for Latvia, Germany, and the United Kingdom. Finally, manufacturing of Altura has started in the company’s United Kingdom facility, with a full transition planned for Q3 of 2016.

Lombard Medical intends to file for an investigational device exemption with the US Food and Drug Administration in 2016 in order to begin recruitment for a United States clinical study later in 2016.

In the company’s announcement, Dierk Scheinert, MD, commented, “The new Altura endograft brings a straightforward, easy-to-use design to treat AAAs. The device features an ultra-low-profile 14-F delivery system that is ideal for a percutaneous approach that simplifies the procedure. The design also eliminates the need for a contralateral cannulation step, while using a retrograde delivery of the iliac limb sections, further streamlining the procedure and providing a safer, more consistent device deployment.”

“I believe it has the potential to become a mainstream device for AAA repair,” concluded Dr. Scheinert, who is Head of the Department of Interventional Angiology at the University Hospital Leipzig in Leipzig, Germany.