The world’s first device designed specifically to address the unique challenges of acute type A aortic dissection, specifically DeBakey Type I (ATAD I).
DANE Prevention – The stent-supported cuff of the AMDS and expansion of the device from the arch distally elevates and support the intimal flap. This reduces tension on the intima, media, and the suture line, avoiding the formation of DANEs in the friable anastomosis.1, 2
Positive Aortic Remodeling – By avoiding DANE and stabilizing the true lumen, AMDS induces positive aortic remodeling, defined by 3 key measures: true lumen expansion, false lumen reduction, and total aortic diameter stabilization.3
Malperfusion Resolution – AMDS-induced expansion of the true lumen demonstrates effective resolution of vessel malperfusion.1
Uninhibited Flow to Supra-Aortic Vessels (SAVs) – The novel stent design of AMDS allows for uninterrupted flow into the native SAVs without surgical manipulation (i.e., bypass).1
Minimal Time Added to Operation – AMDS prolongs the circulatory arrest time of the hemiarch procedure by only a few minutes, with additional time for suturing, without adding significant technical complexity.1,4
Clinical Evidence
Proven Clinical Results
AMDS Prevents DANE and Resolves Malperfusion, Inducing Positive Aortic Remodeling.
True Lumen Expansion
DARTS study demonstrated sustained true lumen expansion ≥ 5.0 mm in aortic Zones 1-4 from pre-op to 3 years, post-op. 3
False Lumen Reduction
DARTS study demonstrated complete or partial false lumen thrombosis in the majority of patients in Zones 0-4 at 3 years post-op.3