Artivion
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- -
- Employees
- 1.5K
- Market Cap
- -
- Introduction
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.
Endospan's NEXUS Aortic Arch Stent-Graft Shows Promising 30-Day Results in FDA TRIOMPHE Trial
• Endospan's NEXUS Aortic Arch Stent-Graft System demonstrated encouraging 30-day outcomes in the TRIOMPHE IDE clinical study, with no Type I or III endoleaks observed in the Dissection arm.
• The study reported a 5.6% rate of disabling stroke and 9.2% 30-day mortality, suggesting potential as a less invasive alternative to open surgery for high-risk patients with aortic arch disease.
• Investigators highlighted the significance of the low stroke rate as a notable achievement, with longer-term follow-up data still pending to further evaluate the device's safety and effectiveness.
Artivion's AMDS Hybrid Prosthesis Receives FDA Humanitarian Device Exemption for Acute Aortic Dissections
• 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 Completes Enrollment in TRIOMPHE Trial for NEXUS Aortic Arch Stent Graft
• 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.
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