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The Nitinol Enhanced Device (NED) is intended for arterial and venous embolization in the peripheral vasculature. This device is not intended for neurovascular use.

The NED system is comprised of polymer-based occlusion devices intended for embolization procedures in 3-6 mm vessels of the peripheral vasculature. It is intended to be used with 0.027" labeled microcatheters. The NED consists of three components: the NED implants (framing and packing), the delivery system, which is supplied engaged with the implant, and the transfer/removal tool. The NED framing and packing implants are permanently implanted and include a 0.016" diameter polymer filament which compacts upon delivery. The implants work together to obstruct blood flow in the vessel. The framing implant is deployed first to form the initial pack and create a backing for additional implants to be deployed in accordance with physician discretion. The deployment of the framing implant is followed by the deployment of packing implants, the quantity of which is determined by the physician based on vessel size and occlusion. The physician also has the option to finish the implant pack with another framing implant. The UHMWPE braid on the implants and the nylon 6,6 tails on the packing implant provide a scaffold for thrombus to form and attach. The combination of the mechanical obstruction of blood flow and the formation of thrombus result in vessel occlusion. The delivery system is comprised of two components: the implant pusher and the introducer. The NED delivery system comes with the NED implant pre-loaded in its package, sterile and ready for use. The pusher is a 180 cm long 0.022" diameter single super-elastic nitinol wire with a 30 cm PTFE jacket and a platinum/iridium radiopaque marker near its distal end. The nitinol pusher coupler is located on the distal end of the pusher, which as described above, serves to engage with the coupler on the implant's proximal end. The NED pusher allows the physician to reposition the NED to ensure preferred vessel positioning prior to detachment. Further, the detachment mechanism provides the physician the ability to completely withdraw the NED before detachment, should a condition result that necessitates its removal. The introducer is a PTFE tube used to protect the implant and maintain coupling between the implant and pusher prior to use (as described in Section 2.1). Once the implant and pusher are transferred into the delivery microcatheter, the introducer is discarded. The transfer/removal tool is a disposable accessory included with the device that attaches to the hub of the delivery microcatheter prior to inserting the implant. The purpose of the transfer/removal tool is to facilitate the transfer of the implant from the device introducer into the delivery microcatheter hub and to facilitate the removal of the implant from the delivery microcatheter if necessary. The transfer/removal tool is designed to fit 0.027" labeled microcatheters. The tool is comprised of an ABS and PC Luer adapter assembly bonded with medical grade Dymax 1162-M UV adhesive. The tool utilizes a spring-loaded 300 series stainless steel tube to form the lumen.