Publications
As a breakthrough technology, the MFM® has been studied and discussed in numerous publications.
CONCEPT PUBLICATIONS
AORTIC PUBLICATIONS
PERIPHERAL PUBLICATIONS
Outcomes
The Multilayer Flow Modulator (MFM®) technology represents a paradigm shift in the treatment of aneurysms. Since 2009 (for the peripheral device) and 2011 (for the aortic device), more than 4000 MFM® devices have been implanted, demonstrating a strong record of safety and performance. Clinical investigations — some completed and published, some currently ongoing — also demonstrate the unique capabilities of the MFM® when it comes to preserving the patency of branch arteries and preventing serious complications such as spinal cord ischemia and renal failure.
Safety and Performance
PERIPHERAL MFM®
AORTIC MFM®
PERIPHERAL MFM®
REFERENCES
AORTIC MFM®
Largest peripheral series published – Ruffino et al., 2012
Largest Aortic series published – Hynes et al., 2016
Ruffino, M. A., Rabbia, C., & Italian Cardiatis Registry Investigators, G. (2012). Endovascular repair of peripheral and visceral aneurysms with the Cardiatis multilayer flow modulator: one-year results from the Italian Multicenter Registry. J Endovasc Ther, 19(5), 599-610. doi:10.1583/JEVT-12- 3930MR2.1
Hynes, N., Sultan, S., Elhelali, A., Diethrich, E. B., Kavanagh, E. P., Sultan, M., . . . Morris, L. (2016). Systematic Review and Patient-Level Meta-analysis of the Streamliner Multilayer Flow Modulator in the Management of Complex Thoracoabdominal Aortic Pathology. J Endovasc Ther. doi:10.1177/1526602816636891
PERIPHERAL MFM®
ANEURYSM PREVALENCE
AORTIC MFM®
PERIPHERAL MFM®
MEAN AGE
AORTIC MFM®
68 Y (19-87)
68.8 Y (~12.3 Y)
PERIPHERAL MFM®
SEX RATIO
AORTIC MFM®
M 87% - F 13%
M 81% - F 19%
PERIPHERAL MFM®
TECHNICAL SUCCESS
AORTIC MFM®
100%
98.5%
PERIPHERAL MFM®
SURVIVAL RATES
AORTIC MFM®
PERIPHERAL MFM®
BRANCH PATENCY
AORTIC MFM®
At 6 months: 98.1%
At 1 year: 97.9%
97.8%
at latest documented follow-up
at latest documented follow-up
PERIPHERAL MFM®
ANEURYSM RUPTURE
AORTIC MFM®
0%
1.2%
PERIPHERAL MFM®
ANEURYSM THROMBOSIS
AORTIC MFM®
Complete aneurysm thrombosis :
At 1 month: 86.5%
At 16 months: 94.2%
At 12 months: 93.3%
Complete or partial thrombosis reported
PERIPHERAL MFM®
COMPLICATIONS
AORTIC MFM®
Freedom from complications at 1 year: 83%
0% renal impairment
0% neurologic complications
PERIPHERAL MFM®
ENDOVASCULAR REINTERVENTIONS
AORTIC MFM®
3.7%
11.1%
PERIPHERAL MFM®
CONVERSION TO OPEN SURGERY
AORTIC MFM®
1.9%
1.2%
Studies
STRATO
The STRATO trial of the Aortic MFM® enrolled 23 patients suffering from complex Crawford type II and III thoracoabdominal aortic aneurysms (TAAA) between April 2010 and February 2011.
Three-year safety and performance results are very solid with 11 patients remaining alive and no device-related deaths. The ratio of aneurysm flow volume to total volume decreased 83%, while the ratio of thrombus volume to total volume increased 159%. There were no cases of spinal cord injury and no cases with renal or peripheral complications. Branch patency was 97%.
A 65-year-old patient diagnosed with a 56mm Descending Thoracic Aorta Aneurysm (DTAA) comprising the origins of multiple intercostal arteries, presenting also a medical history of smoking, hypertension and peripheral artery disease underwent endovascular treatment with the MFM® device. At 60 months, the lesion was stabilized with full thrombosis of the aneurysmal sac and no issues of Spinal Cord perfusion.
STREAMLINER
The international prospective, nonrandomized Bifurcated Aortic MFM® STREAMLINER study is currently screening and enrolling patients suffering from complex thoracoabdominal aortic aneurysms at up to 12 centers in Europe, Israel, Morocco and Turkey. As of June 2016, 23 patients had been enrolled, out of a targeted total of approximately 40.
In an interim report of results for the first patients 6 months of follow-up, technical success was 100%, with 0% mortality. At 1 month, flow into the aneurysm was decreased for 88.9% of patients. At 6 months, 100.0% of patients had decreased flow, and 10.0% had total aneurysm thrombosis. The patency of covered branch vessels was 100% at 1 and 6 months. There were no cases of device migration and no endoleaks.
