Nectero Medical announced that the Food and Drug Administration (FDA) has granted Fast Track designation for the Nectero Endovascular Aneurysm Stabilization Treatment (Nectero EAST) system to treat patients with infrarenal abdominal aortic aneurysms (AAAs) of maximum diameter 3.5–5cm. The company states that it is initiating a randomized, controlled Phase II/III clinical trial (stAAAble) to evaluate the product’s safety and effectiveness.
The designation allows for more frequent meetings with the FDA to ensure appropriate data collection in support of drug approval, enables eligibility for accelerated approval and priority review, and supports rolling review, where individual sections of Biologic License Application (BLA) or New Drug Application (NDA) can be submitted once completed rather than waiting for the entire application to be reviewed, the company stated in a press release.
The Nectero EAST system is a single-use, endovascular system for the treatment of infrarenal AAA. It is comprised of a dual-balloon delivery catheter and stabilizer mixture containing pentagalloyl glucose (PGG). The system 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.
Nectero Medical noted that the procedure does not require any specialized tools or training, takes less than an hour to complete, leaves no permanent implant behind and does not preclude any future interventions. If successful, the Nectero EAST system may offer patients with smaller AAAs a first approved therapeutic option beyond surveillance.