Lombard Medical Technologies (NSDQ:EVAR) yesterday released 5-year results from the Pythagoras trial of its Aorfix, which aimed to evaluate the safety and effectiveness of the stent graft in treating highly angulated aortic necks or tortuous aortoiliac anatomy.
A presentation based on data from the study was presented at the 2016 Society for Vascular Surgery’s annual meeting in National Harbor, Maryland this week, the company said.
A total of 87% of surviving patients in the 218 patient trial were followed-up with at 5 years, Lombard said, with 60% of angled neck patients showing significant aneurysm sac shrinkage. Patients with low angle aortic necks reported similar outcomes, the company 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%). 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,” Dr. Mahmoud Malas of the Johns Hopkins Bayview Medical Center said in a press release.
All cause mortality, aneurysm-related mortality, secondary intervention and aneurysm rupture at 5 years were equivalent to reports from EVAR trials of patients with normal anatomy, the company said.
“These 5-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. These results clearly demonstrate that Aorfix is the only evidence-based and on-label solution for treating this patient population,” CEO Simon Hubbert said in a prepared statement.
Last July, Lombard CEO Simon Hubbert said the stent graft maker is looking to M&A to grow beyond the abdominal aortic aneurysm repair market, aiming to escape being a 1-product company either via acquisition or a distribution deal with a larger medical device company.
Discussing Lombard’s 2nd-quarter results July 27, Hubbert referenced the $110 million buyout of Aptus Endosystems by Medtronic (NYSE:MDT), observing that the crowded and competitive abdominal aortic aneurysm repair market is driving consolidation.
Lombard could look to acquire assets in the vascular surgery market to take advantage of its existing sales force, Hubbert said.