Artivion Receives US FDA Approval for AMDS Hybrid Prosthesis to Treat Acute Aortic Dissections

FDA Approves Artivion's AMDS Hybrid Prosthesis

Artivion, Inc. has received premarket approval (PMA) from the United States Food and Drug Administration (FDA) for its AMDS Hybrid Prosthesis, a device designed to treat patients with acute DeBakey Type I aortic dissections accompanied by clinical or radiographic malperfusion.

According to the company, this patient group represents nearly 60% of all acute DeBakey Type I aortic dissection cases in the United States.

The approval also removes the need for hospitals to obtain Institutional Review Board (IRB) approval before using the device. Under the previous Humanitarian Device Exemption (HDE), hospitals had to complete this extra step before implanting AMDS. With the PMA approval now in place, eligible patients can receive treatment more quickly while hospitals face fewer administrative requirements.

A Device Designed for Life-Threatening Aortic Emergencies

The AMDS Hybrid Prosthesis is the first aortic arch remodeling device developed specifically for treating acute DeBakey Type I aortic dissections.

The device is used together with a standard hemiarch replacement procedure during emergency surgery. It is designed to be deployed quickly without adding significant complexity or operating time.

Unlike traditional surgical repair alone, AMDS helps preserve the patient's native aortic arch. If future treatment becomes necessary, physicians may be able to perform less invasive procedures instead of another major arch surgery.

Clinical Trial Shows Strong Patient Outcomes

The FDA approval is supported by results from the PERSEVERE U.S. Investigational Device Exemption (IDE) clinical trial.

At the 30-day evaluation, patients treated with AMDS experienced a 72% reduction in all-cause mortality compared with the current standard hemiarch repair procedure.

The study also showed a 54% reduction in major adverse events, including stroke, heart attack, and kidney failure requiring dialysis.

Researchers reported that no patients treated with AMDS developed distal anastomotic new entry (DANE) tears, one of the major complications that can occur after conventional surgery.

Long-Term Results Continue to Support the Device

Two-year follow-up data presented at the Society of Thoracic Surgeons Annual Meeting in February 2026 showed that the clinical benefits continued over time.

Patients maintained stable aortic dimensions, experienced continued expansion of the true aortic lumen, and had no new DANE tears during follow-up.

The study also reported no unexpected repeat aortic surgeries, while additional deaths were limited to causes unrelated to the device or procedure.

Researchers will continue monitoring trial participants for up to five years to evaluate long-term aortic remodeling and clinical outcomes.

Addressing a Serious Medical Need

Acute DeBakey Type I aortic dissection is one of the most dangerous cardiovascular emergencies.

Around 6,000 patients in the United States develop this condition every year. Without treatment, the risk of death increases by approximately 1% every hour after symptom onset, and nearly half of all untreated patients die within the first 48 hours.

Although standard surgery repairs the primary tear in the aorta, it often leaves the remaining damaged sections untreated. Many patients later develop complications such as organ damage, reduced blood flow, aneurysm formation, or require additional surgeries.

The company estimates that nearly 45% of patients undergoing conventional hemiarch repair develop DANE tears, increasing the risk of future complications.

Commercial Opportunity Expands Following FDA Approval

Artivion believes the PMA approval will allow the company to expand access to the AMDS Hybrid Prosthesis across hospitals in the United States.

The company estimates the annual U.S. market opportunity for the device at approximately $150 million.

Having already established commercial operations during the earlier HDE launch, Artivion expects the removal of the IRB requirement to support faster adoption among hospitals and surgeons.

Building a Broader Aortic Disease Portfolio

Artivion says the approval strengthens its growing portfolio of products designed for complex aortic disease treatment.

The company recently expanded its aortic business through the acquisition of the PMA-approved NEXUS system and continues enrolling patients in the ARCEVO LSA clinical trial.

With these products, Artivion aims to provide surgeons with a complete range of treatment options for aortic arch diseases.

About the AMDS Hybrid Prosthesis

The AMDS Hybrid Prosthesis is designed to remodel the aortic arch during surgery for acute DeBakey Type I aortic dissections.

The device is implanted during standard ascending aorta replacement procedures and preserves the native aortic arch while helping reduce complications associated with conventional surgical repair.

Before receiving full FDA approval, the device had already been introduced in selected international markets, including Europe, Canada, and several countries across Asia.

About Artivion

Artivion is a medical device company headquartered near Atlanta, Georgia, specializing in products for cardiac and vascular surgery.

The company's product portfolio includes aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable human cardiac and vascular tissues. Its focus remains on developing technologies that help surgeons treat some of the most complex aortic diseases.

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