Artivion Announces Presentation of Late-Breaking Clinical Data at the 38th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting
5-Year Data from the AMDS DARTS Trial Demonstrates Positive Aortic Remodeling with 94% of Patients Free from Unanticipated Reoperation
30-Day Data from the AMDS PERSEVERE Trial Shows Cerebral Malperfusion Resolution in 90% of Affected Subjects Post-AMDS Implantation
1-Year Data from the NEOS Study Indicate E-vita Open Neo is Safe and Effective in the Treatment of Aortic Arch Pathologies with Low Combined Major Adverse Events Rate
The presentation regarding the AMDS DARTS trial highlighted 5-year aortic remodeling data that demonstrate positive, durable patient outcomes following AMDS implantation. The presentation on the 30-day AMDS PERSEVERE trial data showed cerebral malperfusion resolution for 90% of affected subjects at 30-days post-AMDS implantation. Additionally, the presentation on the 1-year data from the NEOS study showed E-vita Open Neo is safe and effective for the treatment of acute and chronic aortic arch pathologies with a lower combined major adverse event rate compared to the market leading alternative.
"We were thrilled to command such a strong presence at EACTS, with data from our AMDS and E-vita Open Neo clinical trials dominating the aortic focused late-breaking science session," said
Late-Breaking 5-Year Data from AMDS DARTS Trial:
The abstract titled 5-Year Results on Aortic Remodeling in the Dissected Aorta Repair Through Stent (DARTS) Implantation Trial reports five years of clinical follow-up on the remaining 25 of 46 study participants with acute DeBakey Type I dissection who were treated with a proximal aortic repair and AMDS. The results demonstrate durable benefits out to at least 5 years over the baseline:
- 94% of patients were free from aortic reoperation compared to existing literature on hemiarch-only outcomes which report freedom from late aortic arch reoperation as low as 76%,
- 95% of patients were free from total aortic diameter (TAD) growth >5 mm between the 3-year and 5-year follow up periods at aortic zones 2 and 4; and
- In contrast, existing literature on hemiarch-only outcomes suggest a majority of patients have early TAD growth in the proximal descending aorta. Aortic growth can lead to increased risk of rupture or dissection, and reoperation.
Principal investigator Dr.
Late-Breaking 30-Day Data from AMDS PERSEVERE Trial:
The abstract titled AMDS Hybrid Prosthesis Improves Cerebral Malperfusion in Acute DeBakey Type I Dissection- Early Results of the PERSEVERE Study focuses on cerebral blood flow across the full 93 study participant IDE cohort at 30-days following AMDS implantation. 20% of patients (19 of 93 patients) presented with symptomatic pre-operative cerebral malperfusion including stroke, transient ischemic attack, delirium or other mental status changes. The 30-day data showed resolution of cerebral malperfusion in the vast majority of patients treated with AMDS. More specifically:
- 90% of patients experienced resolution of their cerebral malperfusion; and
- 63% of those who presented with cerebral malperfusion had complete resolution, while another 26% had no worsening of stroke symptoms
The data compare favorably to hemiarch alone based on data from five articles in the literature, which showed a stroke occurrence rate of 20.9% compared to 10.8% (10 of 93 patients) in the PERSEVERE trial.
Senior author, Dr.
Late-Breaking 1-Year Data from E-vita Open Neo NEOS Study:
The abstract titled E-vita Open Neo in the treatment of acute or chronic aortic pathologies: 1-year results of the European multicenter NEOS study and sub-group analysis includes 161 participants treated with E-vita Open Neo in
- The 1-year mortality rate observed for E-vita Open Neo (9.9%) compared favorably to current market leading device (10.8%); and
- Lower 1 year combined major adverse events rate of mortality, stroke, and paraplegia/ paraparesis occurring after treatment with E-vita Open Neo (17% vs 23.1% for current market leading device).
Professor Martin Grabenwöger, Head,
About the AMDS DARTS Trial
The AMDS DARTS (Dissected Aorta Repair Through Stent Implantation) trial is a prospective, multicenter, nonrandomized, single-arm trial of 47 patients evaluating the safety and efficacy of the AMDS Hybrid Prosthesis for the treatment of Acute DeBakey Type I (ADTI) dissection. Trial results supported regulatory approvals for AMDS in
About the AMDS PERSEVERE Trial
The AMDS PERSEVERE trial is a prospective, multicenter, non-randomized clinical trial to determine if patients with ADTI dissection can be treated safely and effectively using the AMDS Hybrid Prosthesis. The trial is designed to support the company's forthcoming application to the
Full 30-day IDE data from the PERSEVERE trial presented at the
Data presented from the PERSEVERE trial at the 104th
About the E-vita Open Neo NEOS Study
The E-vita Open Neo NEOS study is an observational, multicenter study to determine the safety and clinical performance of E-vita Open Neo Stent Graft System in the treatment of acute and chronic aneurysm and dissection in the ascending aorta, aortic arch and descending thoracic aorta. The observational study consists of 161 patients with acute or subacute type A aortic dissection, chronic type A aortic dissection or thoracic aortic aneurysm enrolled at 12 centers in
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