Lombard Medical Reports Positive Five-Year Aorfix™ Endovascular Stent Graft Clinical Results in AAA Patients with Challenging Anatomy

IRVINE, Calif., Lombard Medical, Inc., a medical device company focused on Endovascular Aneurysm Repair (EVAR) of abdominal aortic aneurysms (AAAs), today announced positive clinical results from The Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft (PYTHAGORAS trial) at the 2016 Society for Vascular Surgery Annual Meeting in National Harbor, Maryland.  The PYTHAGORAS trial is a prospective, controlled, multicenter U.S. trial designed to evaluate the safety and effectiveness of the Aorfix endograft for the treatment of highly angulated aortic necks or tortuous aortoiliac anatomy. 

Key highlights from the PYTHAGORAS trial clinical results include:

• 218 patients were enrolled in the U.S. trial, 151 of which had high neck angles; 87 percent of surviving patients were followed up at 5 years. 
• The core lab reported no type 1 or type 3 endoleaks in any annual CT imaging follow up after the first year. 
• 60 percent of angled neck patients had significant aneurysm sac shrinkage at 5 years. Low angle patients had similar outcomes, illustrating the tolerance of Aorfix to extreme angulation. 
• All-cause mortality, aneurysm-related mortality, secondary intervention and aneurysm rupture rates over 5 years were compared with the Lifeline Registry of U.S. EVAR trials in normal anatomy and were found to be equivalent.  There were no significant differences between Aorfix results in standard and highly angulated necks. 

Mahmoud B. Malas, MD, Associate Professor of Surgery, Director of Endovascular Surgery, Johns Hopkins Bayview Medical Center, said, “The U.S. PYTHAGORAS trial is the first EVAR clinical trial to include a majority of highly angulated (greater than 60 degree) infra-renal aortic necks as well as a higher percentage of female patients (29 percent).  Moreover, the suitability of patients to be included was determined by the investigators rather than the Company, resulting in many more ‘real-world’ cases being recruited.  Angulation alone has been associated with worse outcomes in EVAR and unfortunately, female EVAR patients usually have complication rates that far exceed those of males.  These factors and the addition of ‘real-world’ anatomy made the study group of patients highly challenging from many perspectives.  Pertinent outcomes were better than or similar to trials that did not have these risk factors.  The results attest to the long-term durability of the Aorfix design and support the use of this endovascular option, which is ‘on-label’ even in patients with hostile anatomy, including highly angulated aortic necks.”

“These five-year clinical results validate the unique Aorfix helical design in one of the largest prospective clinical trials ever designed to study a challenging and high risk population,” said CEO Simon Hubbert.  “These results clearly demonstrate that Aorfix is the only evidence-based and on-label solution for treating this patient population.”

Dr. Malas presented “Long-Term Outcomes of the PYTHAGORAS U.S. Clinical Trial of the Aorfix Endograft for EVAR in Patients with Highly Angulated Necks” at the 2016 Vascular Annual Meeting of the Society of Vascular Surgery on Saturday, June 11, 2016, during the Plenary Session of Late Breaking Clinical Trials.

EVAR is associated with significantly lower morbidity and mortality compared with open repair, and is the preferred means to treat abdominal aortic aneurysms.  However, there are a number of anatomical factors that limit the applicability of EVAR to exclude approximately 20 percent of the U.S. patient population.  Severe infra-renal aortic neck angulation is one major limitation to the use of EVAR and as a result, most manufacturers exclude highly angulated aortic necks from their aortic stent-graft instructions for use.

Source: Lombard Medical, Inc.