Nectero’s EAST System Gains FDA Fast Track Designation

August 24, 2023—Nectero Medical announced that the FDA has granted a Fast Track designation for the Nectero endovascular aneurysm stabilization treatment (Nectero EAST) system to treat patients with small- to midsized infrarenal abdominal aortic aneurysms (maximum diameter, 3.5-5 cm).

In the company’s announcement, the Nectero EAST system is described as a single-use, endovascular system composed 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 potentially reduce the risk of further degradation.

Nectero also noted that the procedure does not require any specialized tools, takes less than 1 hour to complete, leaves no permanent implant behind, and does not preclude any future interventions.

According to the company, the FDA’s Fast Track designation will help accelerate the system’s regulatory review pathway.

“This designation reinforces Nectero Medical’s belief that the Nectero EAST System has the potential to address a large segment of patients who suffer from a serious progressive disease with no proven treatment options,” commented Jack Springer, President and Chief Executive Officer of Nectero Medical, in the company’s announcement. “Available therapies are reserved primarily for patients who fall into the highest-risk category.”

In July 2023, Nectero announced the Nectero EAST system’s safety and effectiveness would be evaluated in a randomized, controlled Phase II/III clinical trial (STAAABLE).