FDA Fast Track Designation Given to Nectero EAST System for AAA Treatment
Nectero Medical has been granted Fast Track designation by the US FDA for the Nectero Endovascular Aneurysm Stabilization Treatment (Nectero EAST) System to treat patients with infrarenal AAAs, maximum diameter 3.5-5.0 cm. Nectero Medical is initiating a randomized, controlled Phase II/III clinical trial (stAAAble) to evaluate the product’s safety and eﬀectiveness.
“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 therapies are reserved primarily for patients who fall into the highest-risk category,” said Jack Springer, President and Chief Executive Oﬃcer of Nectero Medical. “We are proud to be advancing a treatment 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 abdominal aortic aneurysms (AAA). It is estimated that >1M Americans are living with AAA and ~60,000 undergo treatment each year; complications of AAA account for approximately 10,000 deaths in the US annually. Available treatments are primarily reserved for AAAs larger than 5.0/5.5 cm
(female/male) in diameter, symptomatic patients, or rapidly expanding aneurysms. Smaller AAAs are traditionally monitored with serial ultrasound or CT surveillance. Patients with small- and mid-sized aneurysms carry a .5-5% annual risk of rupture. The Nectero EAST System 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. 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. If successful, the Nectero EAST System may oﬀer patients with smaller AAAs a ﬁrst approved therapeutic option beyond surveillance.