The first pivotal FDA trial data for endovascular aortic arch repair in Zone 0 shows promising results for patients with complex aortic arch pathologies. Endospan recently presented 30-day outcomes from the statistical Dissection Primary Arm of its TRIOMPHE Investigational Device Exemption (IDE) clinical study at the American Association for Thoracic Surgery (AATS) Annual Meeting in Seattle.
The NEXUS Aortic Arch Stent-Graft System, designed to treat aortic arch diseases through minimally invasive techniques, demonstrated encouraging early results that could potentially transform treatment options for patients who would otherwise require invasive open-chest surgery.
Study Design and Patient Population
The TRIOMPHE study is a prospective, multicenter, three-arm trial evaluating the safety and effectiveness of the NEXUS system in patients with various aortic arch pathologies, including dissections, aneurysms, and penetrating aortic ulcers/intramural hematomas (PAU/IMH). The current data presentation focused specifically on the Dissection arm, which included 54 patients.
The trial represents a significant milestone as the first pivotal IDE study to evaluate endovascular aortic arch repair in Zone 0, the most proximal segment of the aortic arch.
Key Clinical Outcomes
The 30-day results revealed several important findings:
- 0% operative mortality
- 9.2% 30-day mortality (5 patients)
- 5.6% overall disabling stroke rate (3 patients)
- 1.9% post-bypass (1 patient)
- 3.7% post-NEXUS implantation (2 patients)
- No reported cases of renal failure or paraplegia
- No Type Ia, Type Ib, or Type III endoleaks observed in core lab analysis
These results suggest that the NEXUS device may offer an acceptable alternative to traditional open aortic arch replacement for select high-risk patients.
Expert Perspectives
Dr. Brad Leshnower, National Cardiac Principal Investigator for the TRIOMPHE study, expressed optimism about the findings: "The 30-day data from the TRIOMPHE study are highly encouraging for the treatment of aortic arch disease. The low stroke rate, in particular, is a significant achievement. This data is very promising while we await 1-year follow-up of the study patients."
Dr. Ross Milner, National Vascular Principal Investigator, highlighted the potential clinical impact: "As a vascular surgeon, I am excited about the potential of the NEXUS Aortic Arch Stent-Graft to provide a less invasive treatment option for patients with complex aortic arch pathologies."
Clinical Significance
Aortic arch disease has traditionally been treated with open surgical repair, which carries significant risks including stroke, paralysis, and death. The procedure typically requires cardiopulmonary bypass, deep hypothermic circulatory arrest, and extended hospital stays with lengthy recovery periods.
Endovascular approaches have revolutionized treatment for abdominal and descending thoracic aortic pathologies, but the complex anatomy of the aortic arch—with its vital branch vessels to the brain and arms—has presented unique challenges for minimally invasive approaches.
The NEXUS system aims to address these challenges with its specialized design for the aortic arch, potentially offering patients a less invasive option with reduced procedural risks and faster recovery times.
Company Perspective and Future Directions
Kevin Mayberry, CEO of Endospan, commented on the significance of these initial results: "We are very encouraged by the results of the first ever presented data of Endovascular Aortic Arch Repair in Zone 0 in a Pivotal IDE Study. We look forward to continue our leadership in clinical development of Aortic Arch repair in the future."
The TRIOMPHE study is ongoing, with longer-term follow-up expected to provide further insights into the safety and effectiveness of the NEXUS system. One-year outcomes will be particularly important in assessing the durability of the repair and the long-term impact on patient outcomes.
Regulatory Status
The NEXUS Aortic Arch Stent-Graft System has already received CE Mark approval and is commercially available in Europe. In the United States, it remains investigational, with the TRIOMPHE study serving as a pivotal trial for potential FDA approval.
Endospan, headquartered in Herzlia (Tel Aviv), Israel, positions itself as a pioneer in endovascular solutions for aortic arch disease. The company's focus on this challenging anatomical area addresses a significant unmet need in vascular surgery and interventional cardiology.
