Microvention enrols first patient in US clinical trial to test new flow diverting stent

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The Fred (Flow Redirection Endoluminal Device) system is a dual-layer stent that is CE marked in European countries and several other international markets where clinical cases have already been performed.

The first patient was enrolled by Aquilla S Turk, director of Neurointerventional Division and principal investigator at the Medical University of South Carolina, USA, who said: “The Fred system was successfully deployed to treat a recurrent ophthalmic artery aneurysm that had previously been treated with embolic coils, and the flow diverter device provided the best option for long-term treatment durability. The Fred system was easy to deliver and we believe it represents a step forward in flow diversion stent technology.”

Richard Cappetta, president and CEO of Microvention noted that, “The Fred system study is intended to provide clinical evidence that Microvention’s next-generation flow diverter device can effectively treat these difficult aneurysms, and offer new endovascular treatment options for physicians. The enhanced visibility and ease of delivery and deployment, key features of the Fred system device, will hopefully result in improved clinical outcomes.”

A press release from the company stated that the Fred system is a uniquely paired, integrated dual-layer (stent-within-a-stent) of self-expanding nitinol braided design, which is simultaneously deployed by a single operator through a .027 (0.69mm) inner diameter Headway 27 microcatheter.

The higher radial force outer stent, along with the low porosity-high metal surface area inner stent, unite to provide superb ease of use, enhanced stent opening, improved vessel apposition and fluoroscopic visibility, to help reduce and redirect blood flow into the aneurysm sac. Further, the press release stated that the Fred system offers additional benefits over first generation flow diversion devices, by its ability to be partially deployed, retrieved and accurately repositioned/redeployed, without the need for a torque device.

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