Kips Bay Medical launches clinical trials in Europe to support FDA investigational device exemption for eSVS vascular mesh.
The eSVS is designed to help keep vein grafts open in patients undergoing coronary artery bypass surgery, according to the company's brochure.
The device is comprised of a flexible, knitted sleeve that fits around the outside of the vein in order to reduce vessel wall stress and mitigate the potential for vessel injury.
Minneapolis-based Kips Bay plans to launch the eMesh I study in order to demonstrate the initial safety and performance of the eSVS mesh in order to obtain FDA approval to run a pivotal study.
The company further noted that it was forming its response to the FDA's rejection of its previous IDE application.
In September 2011 the FDA issued Kips Bay a non-approvable letter, asking for more information on the eSVS mesh before granting IDE approval for perform pivotal human trials.
That decision sent KIPS shares plummeting 34% to an new all-time low in a single day.
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