Flow Modification Device Treats Aortic Diseases

A novel multilayer flow modulator (MFM) stent shows promise as a treatment for thoracoabdominal aortic aneurysm (TAAA), according to a new study.

Researchers at Galway University Hospital (Ireland) reported the one-year results of 243 patients treated worldwide for aortic aneurysm (AA) and dissection with the Cardiatis (Isnes, Belgium) MFM stent. The retrospective review encompasses the first 55 of these patients, who were treated on a compassionate basis in 11 countries. In all, there were 31 TAAA, seven arch aneurysms, three infrarenal abdominal AAs, eight suprarenal AAs, and six type B dissections. The primary endpoint at one year was a composite of rupture and aneurysm-related death. The secondary endpoints were all-cause mortality, visceral branch occlusion, adverse events (stroke and paraplegia), and reintervention.


The results showed that technical success was 98.2%, with no paraplegia or perioperative visceral or renal insult. The mean number of side branches covered was 3.7 per case, and 108 stents were deployed. At one year, aneurysm-related survival was 93.7%, all-cause survival was 84.8%, intervention-free survival was 92.4%, and all of the 202 side branches were patent; there were no stent fractures. At 6 months, the mean rate of sac volume increase was 0.36% per month, resulting in a mean volume increase of 2.14%. At 12 months, the rate of increase had slowed to 0.28% per month, resulting in a total average increase in sac volume of 3.26%. The study was published in the June 2013 issue of the Journal of Endovascular Therapy.

“With physiological modulation of the aneurysm, the MFM offers promise for resolution of complex thoracoabdominal pathology with off-the-shelf availability, but this disruptive technology requires further development and technical refinement,” concluded study coauthors Sherif Sultan, MD, and Niamh Hynes, MD. “Long-term follow-up of the registry patients is mandatory before establishing a randomized controlled study.”

The MFM stents are self-expanding mesh constructs of cobalt alloy wires interconnected in five layers. They are extremely flexible devices with high kinking and fatigue resistance and low total porosity due to their interlocking layers. Through the mechanism of flow modulation, the MFM construct channels blood flow to native side branches, thus laminating and slowing the flow vortices within the aneurysm sac. The MFM is simple and easy to deploy, with minimal impact on patients' comorbid status, rendering it ideal for use in high-risk polymorbid patients.

Related Links:
Galway University Hospital
Cardiatis