Artivion’s AMDS Hybrid Prosthesis Approved by FDA

June 30, 2026—Artivion, Inc. announced that the FDA has approved the company’s AMDS hybrid prosthesis, an aortic arch remodeling device for use in the treatment of acute DeBakey type I aortic dissections with either clinical or radiographic malperfusion.

The company noted that AMDS has been commercially available in select markets globally, including Europe, Canada, and certain countries in Asia.

According to Artivion, the AMDS device is used as a complement to, and in conjunction with, hemiarch replacement without adding technical complexity. It is designed for rapid deployment of the graft in the aortic arch during a standard replacement of the ascending aorta, with deployment adding minimal time to the procedure.

Deployment of the AMDS preserves the native arch, allowing for minimally invasive reinterventions if needed rather than requiring an invasive arch repair. Additionally, it has been shown to significantly reduce the incidence of distal anastomotic new entry (DANE) tears.

The company stated that FDA approval is based on data from the PERSEVERE United States investigational device exemption trial. The prospective, multicenter, nonrandomized clinical trial is evaluating the safety and effectiveness of the AMDS hybrid prosthesis in 93 patients with acute DeBakey type I aortic dissection complicated by malperfusion. Follow up will be conducted through 5 years.

At 30 days, the trial demonstrated a 72% reduction in all-cause mortality and a 54% reduction in primary major adverse events, including stroke, renal failure requiring dialysis, and myocardial infarction, with zero occurrence of DANE tears, compared to the current standard of care hemiarch procedure.

In February 2026, 2-year follow-up data from PERSEVERE that were presented at the 62nd annual meeting of the Society of Thoracic Surgeons that further demonstrated the durability of these benefits, reported Artivion.