This section highlights FDA-related milestones and regulatory updates for drugs developed by Artivion (AORT).
Over the past two years, Artivion has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AMDS and AMDS. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
AMDS DARTS - FDA Regulatory Timeline and Events
AMDS DARTS is a drug developed by Artivion for the following indication: For Cardio-Thoracic Surgery.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AMDS DARTS
- Announced Date:
- October 10, 2024
- Indication:
- For Cardio-Thoracic Surgery
Announcement
Artivion, Inc. announced data from its AMDS DARTS and PERSEVERE trials and E-vita Open Neo study presented in Late-Breaking Science presentations at the 38th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting in Lisbon, Portugal.
AI Summary
Artivion, Inc. announced new clinical data from its AMDS DARTS and PERSEVERE trials as well as the E-vita Open Neo study at the 38th European Association for Cardio-Thoracic Surgery Annual Meeting in Lisbon, Portugal. The AMDS DARTS trial presented 5-year results showing durable aortic remodeling, with 94% of patients remaining free from unanticipated reoperations. In addition, the AMDS PERSEVERE trial demonstrated that 90% of subjects with cerebral malperfusion experienced resolution of their symptoms 30 days after AMDS implantation. Data from the NEOS study further revealed that the E-vita Open Neo device is safe and effective for treating aortic arch pathologies, with a lower rate of major adverse events compared to a leading alternative. These Late-Breaking Science presentations highlight Artivion’s commitment to advancing treatment solutions for complex aortic diseases.
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AMDS Hybrid Prosthesis - FDA Regulatory Timeline and Events
AMDS Hybrid Prosthesis is a drug developed by Artivion for the following indication: Acute DeBakey Type I Aortic Dissections.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AMDS Hybrid Prosthesis
- Announced Date:
- January 27, 2025
- Indication:
- Acute DeBakey Type I Aortic Dissections
Announcement
Artivion, Inc announced data from the AMDS PERSEVERE clinical trial (the "IDE") was presented in a Late-Breaking Science presentation at the 61st Annual Meeting of the Society of Thoracic Surgeons in Los Angeles, California.
AI Summary
Artivion, Inc. recently presented one-year data from the AMDS PERSEVERE clinical trial (IDE) at the 61st Annual Meeting of the Society of Thoracic Surgeons in Los Angeles, California. The trial involved 93 patients with acute DeBakey Type I dissections complicated by malperfusion. The results showed that the AMDS device maintained its benefits over one year, with 80% of patients surviving. Importantly, the data indicated very few cases of new stroke, kidney failure requiring dialysis, or heart attacks. Additionally, no cases of distal anastomotic new entry (DANE) tears were reported, a finding that contrasts with the high occurrence seen in traditional treatments. These positive outcomes suggest that the AMDS device could become a valuable option for surgeons treating this life-threatening condition while also reducing the risk of further complications and the need for additional surgeries.
Read Announcement- Drug:
- AMDS Hybrid Prosthesis
- Announced Date:
- December 9, 2024
- Indication:
- Acute DeBakey Type I Aortic Dissections
Announcement
Artivion, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted a Humanitarian Device Exemption (HDE) for use of the AMDS Hybrid Prosthesis ("AMDS") in acute DeBakey Type I dissections in the presence of malperfusion.
AI Summary
Artivion, Inc. announced that the FDA has granted a Humanitarian Device Exemption (HDE) for its AMDS Hybrid Prosthesis to treat acute DeBakey Type I aortic dissections in patients experiencing malperfusion. This exemption allows the device to be marketed in the U.S. ahead of full Premarket Approval, expected in late 2025. The AMDS is the world’s first aortic arch remodeling device designed specifically for this severe and life-threatening condition, addressing a critical treatment gap where traditional procedures can fall short.
The FDA’s decision was based on promising data from the PERSEVERE US IDE trial, which showed that the AMDS significantly reduced major adverse events, including mortality, stroke, and renal failure, compared to standard procedures. By targeting roughly 40% of these dissections that involve malperfusion, the device offers a new, potentially life-saving option for approximately 6,000 U.S. patients each year.
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