Ascyrus Medical said today that it received breakthrough device designation from the FDA for the stent graft it developed to treat abdominal aortic dissections.
The AMDS device is designed to treat acute Type A aortic dissections, in which the lining of the abdominal aorta becomes detached from the wall of the vessel. Ascyrus won CE Mark approval in the European Union for the device in February.
The Boca Raton, Fla.-based company conducted dissection trials in Canada and Germany that showed a “significant reduction in mortality and re-interventions along with effective malperfusion management.” The company also said there were no device-related adverse events.
“Receiving breakthrough device designation will accelerate our efforts and partnership with the FDA to secure a U.S. approval for the AMDS,” CEO Dr. Ali Shahriari said in the release. “This is aligned with our commitment to offer life-saving and innovative products, supported by rigorous clinical data, to make a difference in patient’s lives. We look forward to close collaboration with the FDA and our clinician partners to continue to advance the treatment options for patients suffering from this deadly disease.”