Nectero Medical's Nectero EAST® System Receives FDA Clearance to Initiate Phase II/III Clinical Trial for Treating Small- to Mid-Sized Abdominal Aortic Aneurysms
Tuesday, July 25, 2023
Nectero Medical, a biotechnology company focused on advancing therapies for aneurysmal disease, has received FDA clearance to conduct a prospective, multi-center, randomized clinical trial known as the "stAAAble Study." The trial aims to assess the safety and effectiveness of the Nectero Endovascular Aneurysm Stabilization Treatment (Nectero EAST®) in patients with infrarenal abdominal aortic aneurysms (AAAs) ranging from 3.5 to 5.0cm in diameter.
The Nectero EAST® System is a unique endovascular solution designed for treating infrarenal abdominal aortic aneurysms. It comprises a dual-balloon delivery catheter and a stabilizer mixture containing pentagalloyl glucose (PGG). By delivering PGG directly into the aneurysmal wall, the system reinforces the aortic vessel wall by binding to elastin and collagen, potentially reducing the risk of further degradation. The procedure is relatively quick, usually taking less than an hour to complete, and does not require specialized tools or extensive training. Additionally, it leaves no permanent implant behind and does not restrict any future interventions.
The success of the Nectero EAST System in stabilizing AAA growth could have a significant positive impact on patients with aneurysmal disease. Abdominal aortic aneurysms currently represent a considerable unmet need in public health, affecting over one million Americans, with approximately 60,000 undergoing treatment annually. These aneurysms contribute to around 10,000 deaths in the U.S. each year.
Currently, surgical or endovascular treatments are primarily recommended for larger AAAs (measuring over 5.0/5.5cm in diameter for females and males, respectively), symptomatic patients, or rapidly expanding aneurysms. However, for smaller aneurysms, randomized clinical trials have not demonstrated any survival advantage from repair, while some patients within this group face an annual rupture risk as high as 5%. Smaller AAAs are typically monitored using serial ultrasound or CT surveillance. If successful, the Nectero EAST System could offer patients with smaller AAAs an approved therapeutic option beyond surveillance, potentially transforming the treatment approach for this condition.