Nectero Medical Receives the US FDA’s IND Clearance of Nectero EAST System to Initiate P-II/III (stAAAble) Study for Small to Mid-Sized Abdominal Aortic Aneurysms
Shots:
- The US FDA has cleared an IND application to initiate a P-II/III (stAAAble) study evaluating the safety & efficacy of Nectero Endovascular Aneurysm Stabilization Treatment (Nectero EAST) in patients with AAAs at multiple sites, primarily in the US. Patient enrolment is expected to initiate in the next few months
- The early P-I clinical results from the first-in-human, small cohort study showed that a single, localized PGG administration to patients with small to medium-sized infrarenal AAAs was safe & demonstrated the potential to slow the growth of AAAs, published in the Journal of Vascular Surgery
- Nectero EAST, a single-use, endovascular system comprised of a dual-balloon delivery catheter and stabilizer mixture containing pentagalloyl glucose
Ref: PR Newswire | Image: Nectero Medical
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