Novel Drug & Emergent Therapeutics | Medical Devices | Cardiology
Promising solutions for Aortic disease – Artivion presents data from three new trials at EACTS
Time to read: 02:24
Published on MedED: 30 October 2024
Originally published: 28 October 2024
Source: Artivion
Type of article: Novel Drug & Emergent Therapy News
MedED Catalogue Reference: MNDC006
Category: Cardiology
Crossreference: Medical Devices
Category tags: aortic arch disease, aortic graft, cardiovascular surgery
Originally published: 28 October 2024
Source: Artivion
Type of article: Novel Drug & Emergent Therapy News
MedED Catalogue Reference: MNDC006
Category: Cardiology
Crossreference: Medical Devices
Category tags: aortic arch disease, aortic graft, cardiovascular surgery
| Product Category | Product Name | Company |
|---|---|---|
| Medical Devices | E-vita Open Neo Stent Graft System | Artivion |
28 October 2024 PR Newire
Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today 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.
Late-Breaking 5-Year Data from AMDS DARTS Trial
The AMDS DARTS Trial is a multicenter, nonrandomized study involving 47 patients with acute DeBakey Type I aortic dissection. It assesses the safety and efficacy of the AMDS Hybrid Prosthesis.
This 5-year follow-up data underscores sustained benefits in aortic remodelling post-AMDS implantation, which contributed to regulatory approvals in Canada, Europe, and globally.
This 5-year follow-up data underscores sustained benefits in aortic remodelling post-AMDS implantation, which contributed to regulatory approvals in Canada, Europe, and globally.
Key Outcomes:
- Aortic Stability: 94% of patients did not need aortic reoperation, outperforming hemiarch-only repair outcomes (76% reoperation-free).
- Controlled Aortic Growth: 95% of patients experienced no significant total aortic diameter (TAD) growth (>5 mm) between years 3 and 5 in key aortic zones, while hemiarch-only treatments often see early TAD growth in the descending aorta
Dr. Michael Moon, Principal Investigator, noted that AMDS effectively stabilizes or reduces TAD, lowering the risk of further dissection or rupture, and providing durable benefits over five years.
Late-Breaking 30-Day Data from AMDS PERSEVERE Trial
The AMDS PERSEVERE Trial's 30-day data reveal promising early outcomes for patients with acute DeBakey Type I (ADTI) aortic dissection, particularly those with cerebral malperfusion, who received the AMDS Hybrid Prosthesis.
This nonrandomized, multicenter trial enrolled 93 U.S. patients with ADTI to evaluate the safety and efficacy of AMDS as a treatment, supporting future FDA premarket approval.
This nonrandomized, multicenter trial enrolled 93 U.S. patients with ADTI to evaluate the safety and efficacy of AMDS as a treatment, supporting future FDA premarket approval.
Key Findings at 30 Days:
• Resolution of Cerebral Malperfusion: Among patients with pre-operative cerebral malperfusion (20% of the cohort), 90% experienced resolution, with 63% achieving full resolution and 26% showing no symptom worsening.
• Reduced Stroke Occurrence: Stroke incidence in the AMDS cohort was 10.8%, a notable improvement over the 20.9% rate seen in similar hemiarch-only procedures.
• Mortality and Major Adverse Events (MAEs): The trial demonstrated a 72% reduction in all-cause mortality and a 54% reduction in primary MAEs compared to the hemiarch procedure, with data showing a statistically significant drop in both mortality and MAEs.
• Aortic Remodeling and DANE Prevention: Data presented at the Society of Thoracic Surgeons (January 2024) and AATS (April 2024) showed favourable aortic remodelling, with over 80% of patients experiencing stable or reduced total aortic diameter (TAD) and no instances of distal anastomotic new entry (DANE) tears.
These early results underscore AMDS’s potential in improving cerebral blood flow, enhancing aortic stability, and reducing complications in patients with ADTI dissection.
Late-Breaking 1-Year Data from E-vita Open Neo NEOS Study
The E-vita Open Neo NEOS study’s 1-year data indicate that the E-vita Open Neo Stent Graft System is a safe and effective treatment option for acute and chronic aortic arch pathologies, with favorable outcomes compared to the current market-leading device.
This observational, multicenter study included 161 participants across Europe and Asia with various aortic pathologies, including acute and chronic type A aortic dissections and thoracic aortic aneurysms.
This observational, multicenter study included 161 participants across Europe and Asia with various aortic pathologies, including acute and chronic type A aortic dissections and thoracic aortic aneurysms.
Key Findings at 1 Year:
• Mortality Rate: The E-vita Open Neo had a slightly lower 1-year mortality rate (9.9%) compared to the market-leading device (10.8%).
• Major Adverse Events (MAEs): E-vita Open Neo had a lower rate of combined MAEs (mortality, stroke, and paraplegia/paraparesis) at 17%, compared to 23.1% with the market leader.
The NEOS study’s 1-year results support E-vita Open Neo’s safety and efficacy in treating complex aortic pathologies with improved mortality and lower adverse event rates relative to the standard device.
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