Artivion has received FDA premarket approval for its AMDS Hybrid Prosthesis to treat acute DeBakey Type I aortic dissections with malperfusion. The approval removes the institutional review board requirement tied to the device's previous Humanitarian Device Exemption, enabling broader U.S. hospital adoption and allowing the company to pursue an estimated $150 million annual market opportunity. The device is the world's first aortic arch remodeling device for this condition and was supported by the PERSEVERE trial, which showed a 72% reduction in all-cause mortality and zero distal anastomotic new entry tears at 30 days. Artivion estimates that approximately 6,000 U.S. patients experience such dissections each year, with the approved indication covering roughly 60% of those cases. The company's shares have traded flat since the announcement, though they are down 50.7% year-to-date.
Globus Medical
Intuitive Surgical IncArtivion IncFDA approval removes IRB requirement, enabling broader adoption and $150M market opportunity.
West Pharmaceutical Services Inc