Global ARCHYTAS Postmarket Registry Begins for Lombard Medical's Aorfix EVAR Device

April 22, 2015—Lombard Medical, Inc. announced the beginning of enrollment in the ARCHYTAS global, randomized, single-arm prospective registry. The postmarket ARCHYTAS registry is designed to quantify the clinical outcomes of endovascular aneurysm repair (EVAR) with the company’s Aorfix stent graft in a broad cross-section of patients with abdominal aortic aneurysms (AAAs).

According to Lombard Medical, the ARCHYTAS registry plans to enroll up to 500 patients at 50 sites worldwide and will follow patients for 5 years. Outcome measures include success at 12 months and freedom from sac expansion, type I and III endoleaks requiring reintervention, rupture, conversion to open surgery, graft migration, and limb occlusion. The study is led by Vincent Riambau, MD, who is Professor and Chief of the Vascular Surgery Division at the Thorax Institute, Hospital Clinic at the University of Barcelona in Barcelona, Spain.

Omar Andres Navarro, MD, enrolled the first patient in the registry, an 89-year-old man with a 64-mm AAA and a challenging 75º aortic neck angulation. Dr. Navarro is Chief of Service, Vascular and Endovascular Department, Dr. Josep Trueta University Hospital in Girona, Spain.

In the company’s press release, Dr. Navarro commented, “Aorfix was deployed easily with a favorable acute outcome, and the patient is doing well. We look forward to monitoring the long-term results of this case and are excited to enroll additional patients into this important study.”

On April 15, Lombard Medical announced the start of enrollment in the United States of the US Food and Drug Administration (FDA)—mandated postmarket surveillance program for the Aorfix in partnership with the Vascular Quality Initiative Endovascular AAA registry.

The FDA approved the Aorfix device in 2013, and it is commercially available in the United States, the United Kingdom, Germany, Spain, Italy, Austria, Switzerland, the Czech Republic, Russia, Greece, Canada, Mexico, Brazil, Japan, Hong Kong, Poland, New Zealand, Argentina, Sweden, Colombia, Ireland, Chile, Peru, and Uruguay, the company noted.