Endospan Secures U.S. Food and Drug Administration Approval for NEXUS® Aortic Arch Stent Graft System
Endospan, a privately held innovator focused on advancing endovascular therapies for complex aortic conditions, has announced a major regulatory milestone with the approval of its NEXUS® Aortic Arch Stent Graft by the U.S. Food and Drug Administration. This landmark decision represents a significant step forward in the treatment of aortic arch disease, particularly for patients who are considered high risk for traditional open surgical repair.
The FDA’s approval of the NEXUS System is supported by one-year data from the TRIOMPHE Investigational Device Exemption (IDE) study, a prospective, multicenter clinical trial designed to evaluate the safety and effectiveness of the device in a challenging patient population. The results demonstrated that the system can effectively treat complex aortic conditions, including chronic aortic dissections, while maintaining an acceptable safety profile. With this approval, Endospan is now positioned to initiate the commercial launch of the NEXUS System in the United States, opening new treatment possibilities for patients and physicians alike.
The NEXUS® Aortic Arch Stent Graft represents a novel approach to endovascular repair of the ascending aorta and aortic arch—areas that have historically been difficult to treat using minimally invasive techniques. Unlike conventional devices, the NEXUS System features a bimodular design that is specifically engineered to replicate the natural anatomy of the ascending aorta and the arch. This tailored design allows for improved alignment and placement within the complex vascular structure, enhancing both procedural success and long-term performance.
One of the defining features of the NEXUS System is its low-profile 20F delivery system, which incorporates a pre-shaped catheter. This design enables physicians to navigate the aortic arch in a single pass, significantly reducing the need for repeated manipulation within the vessel. Minimizing manipulation is particularly important in this region of the body, where excessive movement can increase the risk of complications such as embolization or stroke. Additionally, the system includes an integrated branch component designed to optimize hemodynamic flow, further improving outcomes for patients undergoing the procedure.
The TRIOMPHE study played a central role in securing FDA approval. As a rigorously designed clinical trial, it enrolled high-risk surgical patients who would otherwise have limited treatment options. The one-year outcomes from the study demonstrated that the NEXUS System could safely and effectively address pathology in the ascending aorta—a segment that has long posed significant challenges due to its proximity to the heart and the complexity of its anatomy. Historically, interventions in this area have been associated with high rates of morbidity and mortality, making the development of less invasive alternatives a critical unmet need.
According to Brad Leshnower, the national cardiac surgery co-principal investigator for the TRIOMPHE study, the anatomical design of the NEXUS System addresses many of the technical challenges encountered when treating the ascending aorta and aortic arch. He emphasized that the availability of this minimally invasive solution represents a meaningful advancement for patients with life-threatening conditions who are not suitable candidates for conventional open surgery. The ability to offer an endovascular alternative expands the therapeutic arsenal available to clinicians and may improve outcomes for a vulnerable patient population.
The burden of thoracic aortic arch disease is substantial, with more than 120,000 patients affected each year across the United States and Europe. Despite this high prevalence, only about a quarter of these patients are currently diagnosed or treated. Many individuals remain untreated due to a combination of factors, including the complexity of the disease, limitations in available technologies, and the risks associated with open surgical repair. For patients with unfavorable anatomy or comorbid conditions, the lack of viable treatment options has historically left clinicians with difficult decisions and limited pathways for intervention.
The introduction of the NEXUS System helps to address this gap by enabling transcatheter repair in cases where surgery may not be feasible. By providing a less invasive option, the device has the potential to increase the number of patients who can receive treatment, thereby improving overall disease management and outcomes within the aortic care community. This is particularly important as the field continues to evolve toward minimally invasive approaches that prioritize patient safety and recovery.
Ross Milner, co-principal national investigator for the TRIOMPHE study and a leading expert in vascular surgery, highlighted the collaborative effort behind the development and evaluation of the NEXUS System. He acknowledged the contributions of the investigators, physicians, and clinical staff who participated in the study, noting that their dedication was instrumental in bringing this innovative technology to patients. Milner also underscored the importance of expanding treatment options for complex aortic diseases, which remain among the most challenging conditions in cardiovascular medicine.
From a corporate perspective, the FDA approval represents a defining moment for Endospan. Kevin Mayberry, Chief Executive Officer of the company, described the milestone as a testament to the dedication of the organization and its clinical partners. He noted that the NEXUS System was specifically designed to address the unique challenges of the ascending aorta and aortic arch, and that the positive clinical data from both the TRIOMPHE study and prior European experience support its role as a viable treatment alternative.
Mayberry also emphasized the significance of bringing this technology to the U.S. market, where patients and physicians have long awaited an approved endovascular solution for aortic arch disease. With regulatory clearance now secured, Endospan is focused on executing its commercial strategy and ensuring that the NEXUS System is accessible to healthcare providers across the country.
In summary, the FDA approval of the NEXUS® Aortic Arch Stent Graft marks a major advancement in the field of endovascular therapy. By combining innovative design with strong clinical evidence, the system offers a promising new option for the treatment of complex aortic conditions, particularly in patients who are not candidates for open surgery. As Endospan moves forward with its U.S. launch, the NEXUS System has the potential to reshape the standard of care for aortic arch disease and improve outcomes for thousands of patients each year.
About Endospan
Privately held Endospan, headquartered in Herzliya (Tel Aviv), Israel, is a pioneer in the endovascular repair of aortic arch disease including aneurysms and dissections. Endospan’s NEXUS ® Aortic Arch Stent-Graft System was the first endovascular off-the-shelf system with CE Mark to treat an underserved group of patients diagnosed with a dilative lesion in, or near, the aortic arch and ascending expanding minimally invasive endovascular repair in this anatomical region.
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