The approval marks a transition from the device’s initial Humanitarian Device Exemption status, eliminating the mandatory institutional review board requirements that previously restricted its clinical deployment. By streamlining the path to surgery, the company aims to address a critical segment of the 6,000 annual U.S. cases of acute aortic dissection—a condition where mortality rates can climb to 50% within 48 hours without intervention.
In section Releases
Artivion Secures FDA Approval for AMDS Hybrid Aortic Prosthesis
The U.S. Food and Drug Administration has granted premarket approval to Artivion’s AMDS Hybrid Prosthesis, a device designed to treat acute DeBakey Type I aortic dissections. The regulatory clearance removes previous administrative hurdles for hospitals, allowing for broader and more immediate clinical access to the life-saving technology across the United States.
Data from the PERSEVERE clinical trial provided the foundation for the FDA’s decision. The study reported a 72% reduction in all-cause mortality and a 54% decrease in major adverse events, such as strokes and renal failure, compared to standard hemiarch procedures. Furthermore, the device demonstrated a complete absence of distal anastomotic new entry tears over two years of follow-up. Artivion CEO Pat Mackin noted that the approval validates the clinical findings and positions the company to capture an estimated $150 million annual market opportunity in the U.S. cardiac surgery sector.
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