Nectero Medical today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the Nectero Endovascular Aneurysm Stabilisation 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 randomised, controlled Phase II/III clinical trial (stAAAble) to evaluate the product’s safety and effectiveness.
A press release details that Fast Track designation offers significant advantages to companies developing novel technologies to treat unmet clinical needs. 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.
Each year, FDA limits the Fast Track designation to only a select number of novel drugs that offer the potential to treat a serious disease. “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. Available treatments today address only patients who fall into the highest-risk category with most patients having no proven treatment option,” said Jack Springer, president and chief executive officer of Nectero Medical. “We are proud to be advancing a therapy that has the potential to impact so many lives and are extremely pleased that FDA acknowledged this through our designation.”
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 stabiliser 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 notes that the procedure does not require any specialised 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.
