Nectero Medical has secured fast-track designation from the US Food and Drug Administration (FDA) for its Nectero Endovascular Aneurysm Stabilization Treatment (Nectero EAST) system.
The single-use endovascular system is intended for the treatment of patients with infrarenal abdominal aortic aneurysms (AAAs) with a maximum diameter of 3.5cm–5.0cm.
Nectero EAST consists of a stabiliser mixture containing pentagalloyl glucose (PGG) and a dual-balloon delivery catheter.
The system administers PGG locally to the aneurysmal wall, where it attaches to elastin and collagen, strengthening the aortic vessel wall and lowering further degradation risk.
Designed to finish within an hour, the procedure does not need any specialised tools and leaves no permanent implant.
Furthermore, it does not prevent future interventions.
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The company is commencing a randomised, controlled Phase II/III trial (stAAAble) to assess the safety and effectiveness of Nectero EAST.
Nectero Medical president and CEO Jack Springer said: “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.
“We are proud to be advancing a treatment that has the potential to impact so many lives and are extremely pleased that the FDA acknowledged this through our designation.”
More than one million people in the US are anticipated to live with AAA and approximately 60,000 undergo treatment for this condition each year. The complications of AAA result in roughly 10,000 deaths annually in the country.