Artivion, Inc. engages in the research and development of solutions which address cardiac and vascular surgeons' clinical challenges in treating patients with aortic diseases. Its products include aortic stents and stent grafts, prosthetic heart valves, cryopreserved cardiac and vascular allografts, and surgical sealants. It operates through the Medical Devices and Preservation Services segments. The Medical Devices segment includes aortic stents and stent grafts, surgical sealants, and On-X products. The Preservation Services segment offers cardiac and vascular tissue preservation services. The company was founded on January 19, 1984, and is headquartered in Kennesaw, GA.
Clinical Trials
16
3 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
2
12.5%
Completed
9
56.3%
Not yet recruiting
1
6.3%
Recruiting
1
6.3%
Terminated
3
18.8%
No approval data available
- The FDA has approved Endospan's NEXUS Aortic Arch Stent Graft System, marking the first endovascular off-the-shelf solution for treating aortic arch disease including chronic aortic dissections. - The TRIOMPHE IDE study demonstrated strong clinical outcomes with 90% patient survival from lesion-related death and 90% freedom from disabling stroke at one year in high-risk patients. - The approval addresses a significant unmet medical need, as more than 120,000 patients suffer from thoracic aortic arch disease annually in the U.S. and Europe, with only 25% currently diagnosed or treated. - Artivion holds an option to acquire Endospan within 90 days of FDA approval and has secured a $150 million delayed draw term loan to fund the potential acquisition.
- Artivion's AMDS PERSEVERE trial demonstrated 83% visceral malperfusion resolution and 74% renal malperfusion resolution at 30 days in acute DeBakey Type I aortic dissection patients. - The AMDS PROTECT real-world registry of 141 patients validated positive outcomes with significantly lower complication rates compared to standard care databases. - The AMDS Hybrid Prosthesis represents the world's first aortic arch remodeling device, showing 72% reduction in all-cause mortality and 54% reduction in major adverse events. - Late-breaking data presented at EACTS 2025 supports Artivion's upcoming FDA premarket approval application for this innovative aortic dissection treatment.
- Artivion's AMDS Hybrid Prosthesis has received FDA Humanitarian Device Exemption for treating acute DeBakey Type I aortic dissections with malperfusion. - The AMDS device demonstrated a 72% reduction in all-cause mortality and a 54% reduction in major adverse events in clinical trials. - The HDE allows for commercial distribution in the U.S. while Artivion pursues Premarket Approval, expected in late 2025. - AMDS is the first aortic arch remodeling device, offering a potential $150 million U.S. market opportunity upon full PMA approval.
- Endospan has concluded enrollment in the primary arm of the TRIOMPHE study, evaluating the NEXUS stent graft for aortic arch disease treatment. - The NEXUS device, already CE marked in Europe, aims to provide a less invasive, off-the-shelf solution for complex aortic arch pathologies. - The TRIOMPHE trial, conducted across 30 US and one New Zealand site, will monitor patient safety and efficacy for one year. - Early trial results suggest the NEXUS stent graft demonstrates safety in high-risk surgical patients, potentially revolutionizing aortic arch disease treatment.
