Endospan Completes Enrollment of Primary Arm in TRIOMPHE Study
Endospan, a leader in endovascular solutions for aortic arch disease, has proudly announced the completion of patient enrollment for the primary arm of its TRIOMPHE Investigational Device Exemption (IDE) clinical study targeting the NEXUS® Aortic Arch Stent Graft. This study is critical in assessing the safety and effectiveness of the device in treating patients with aortic arch disease.
About the NEXUS Aortic Arch Stent Graft
The NEXUS Aortic Arch Stent Graft is an advanced bi-modular off-the-shelf device that offers a minimally invasive solution specifically designed for individuals suffering from aortic arch disease. The TRIOMPHE IDE study is a non-randomized, three-arm investigation being conducted at 30 leading aortic centers in the United States, alongside one participating center in New Zealand. This study encompasses a diverse range of aortic arch pathologies, allowing for a comprehensive understanding of the device's performance.
Comments from Key Stakeholders
Kevin Mayberry, CEO of Endospan, expressed his excitement regarding the enrollment achievement: "We are thrilled to announce the completion of enrollment for the primary arm of this significant clinical study. The NEXUS Aortic Arch Stent Graft holds the promise of greatly enhancing patient outcomes in aortic arch disease cases. Our commitment lies in expediting the availability of this innovative technology—already recognized for its effectiveness in Europe—to the U.S. market as soon as possible."
Additionally, Dr. Brad Leshnower from Emory, who serves as the Cardiac National Principal Investigator for the study, shared his perspective: "We are enthusiastic to be implicated in this groundbreaking research. Preliminary results from the TRIOMPHE study, presented at a major conference this year, suggest that the NEXUS system is safely applicable for treating aortic arch disease in high-risk surgical groups with a lower likelihood of stroke. We look forward to the complete results from the entire patient cohort."
Revolutionizing Aortic Arch Treatment
Dr. Ross Milner from UChicago, the Vascular National Principal Investigator, remarked on the transformative potential of the NEXUS device: "This device could revolutionize how we approach treatments for aortic arch disease, providing a less invasive option compared to traditional open surgery. We are very eager to see how this study reveals the midterm durability and overall outcomes for patients."
The company is dedicated to monitoring the safety and effectiveness of patients for a year before submitting their data for FDA approval, reinforcing their commitment to setting high standards of care in this field.
About Endospan
Endospan is a privately held company with its operations headquartered in Herzlia, Israel. This pioneering organization specializes in the endovascular repair of aortic arch conditions, including aneurysms and dissections. The NEXUS® Aortic Arch Stent Graft System stands out as the first endovascular off-the-shelf system that has received a CE Mark, aimed at serving a significantly underserved population diagnosed with issues in or near the aortic arch.
While standard endovascular repairs for Abdominal Aortic Aneurysms (AAA) continue to advance, patients suffering from aortic arch diseases have faced limited options, often resorting to highly invasive open-chest surgeries associated with risks, extended hospital stays, and lengthy recovery times. The NEXUS system represents a beacon of hope for these patients.
Frequently Asked Questions
What is the TRIOMPHE IDE clinical study?
The TRIOMPHE IDE clinical study evaluates the safety and efficacy of the NEXUS Aortic Arch Stent Graft in treating aortic arch disease.
Where is the TRIOMPHE study being conducted?
The study is being conducted at 30 leading aortic centers across the United States and one center in New Zealand.
What is the significance of the NEXUS Aortic Arch Stent Graft?
The NEXUS Aortic Arch Stent Graft is designed to provide a minimally invasive treatment option for patients suffering from aortic arch disease.
What are the next steps for Endospan after enrollment completion?
Endospan plans to monitor patients for one year before submitting their findings for FDA approval.
What differentiates the NEXUS system from traditional treatments?
The NEXUS system offers a less invasive alternative to open surgery, potentially reducing risks and improving recovery times for patients.
