FDA fast-tracks aneurysm stabilization system from Nectero Medical

The EAST system. [Image courtesy of Nectero Medical]Nectero Medical announced today that the FDA granted fast track designation to its endovascular aneurysm stabilization treatment (EAST) system.

Tempe, Arizona–based Nectero designed its EAST system to treat patients with abdominal aortic aneurysm (AAA). These AAAs have a maximum diameter of 3.5 cm to 5 cm. The company plans to initiate a randomized, controlled Phase II/III clinical trial to evaluate its safety and effectiveness.

Nectero EAST features a dual-balloon delivery catheter and stabilizer mixture containing pentagalloyl glucose (PGG). It delivers PGG locally into the aneurysmal wall where it binds to elastin and collagen. This strengthens the aortic vessel wall and potentially reduces the risk of further degradation.

The procedure require no specialized tools and takes less than an hour to complete. It leaves behind no permanent implant and doesn’t preclude any future interventions.


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Nectero Medical completes $19.5M Series C funding round led by Boston Scientific

Nectero Medical announced today that it closed a $19.5 million Series C funding round led by new investor Boston Scientific (NYSE:BSX).

Tempe, Arizona-based Nectero Medical said in a news release that proceeds will be put toward its in vivo and clinical trials for the development of a treatment platform designed to stabilize small- to mid-sized aortic aneurysms by significantly reducing their growth rate.

Nectero said its endovascular aortic stabilization treatment (EAST) has demonstrated impressive early clinical results that suggest the potential ability to dramatically inhibit AAA disease growth. The company designed it to prevent rupture and inhibit further degradation of the aortic tissue with a one-time, catheter-based procedure that locally delivers a proprietary compound.

The company currently has the EAST system under evaluation in treating AAA patients in a multi-site, Phase 1 safety study to see if the system can prevent aneurysmal rupture thr…

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