Fast Track for Abdominal Aneurysm Product

FDA has granted Nectero Medical a fast track designation for its Endovascular Aneurysm Stabilization Treatment (EAST) combination product to treat patients with infrarenal abdominal aortic aneurysms (AAAs) with a maximum diameter of 3.5 – 5.0 cm.

According to the company, EAST is a single-use endovascular product comprising a dual-balloon delivery catheter and stabilizer mixture containing pentagalloyl glucose (PGG). The device delivers PGG locally into the aneurysmal wall “where it binds to elastin and collagen to strengthen the aortic vessel wall and to potentially reduce the risk of further degradation,” the company says. “The procedure does not require any specialized tools, takes less than an hour to complete, leaves no permanent implant behind and does not preclude any future interventions.”

Nectero Medical says it is initiating a randomized, controlled Phase 2-3 clinical trial (stAAAble) to evaluate the product’s safety and effectiveness.