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The IMPEDE-FX Embolization Plug is indicated for use with the IMPEDE Embolization Plug to obstruct or reduce the rate of blood flow in the peripheral vasculature.

The IMPEDE-FX Embolization Plug is a permanent implant, pushable embolization device comprised of a porous, degradable polyurethane thermoset foam plug and a proximal platinumiridium alloy marker band. The foam plug is crimped into a secondary shape to allow delivery through a catheter to the target vessel using a guidewire. Upon deployment in the target vessel and exposure to an aqueous environment and body temperature, the plug will self-expand to its primary shape to embolize the target vessel. The IMPEDE-FX device may only be used in conjunction with the IMPEDE® Embolization Plug System to further enhance vessel occlusion or increase the length of occlusion within the target vessel. It is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. The IMPEDE-FX polyurethane foam undergoes slow oxidative degradation with the majority (> 90%) of the foam remaining at 30 days in a swine intravascular model. The amount of foam degradation was also assessed in vivo in 180-day rat subcutaneous implants and 26-week rabbit intramuscular implants. Analysis of the histology slides from both studies revealed near complete degradation of the polymer foam at the majority of the implant sites in each study. The device is pre-loaded into an introducer sheath which is made of a PEEK tube bonded to a polycarbonate luer hub to facilitate the transfer of the device into the catheter. The device implant is categorized as a permanent implant, blood contacting device, and the introducer is categorized as an external communicating device, limited (< 24 hour) circulating blood contacting device. The assembled unit is supplied to the user e-beam sterile for single use.

The IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.

The IMPEDE Embolization Plug is a permanent implant, blood contacting pushable embolization device comprised of a self-expanding porous, degradable polyurethane-based foam plug, a distal pre-shaped helical platinum-iridium alloy anchor coil, an etched passivated superelastic nitinol core wire, and a proximal platinum-iridium alloy marker band. The device is pre-loaded in the IMPEDE Introducer Sheath which is made of a PEEK tube and a polycarbonate luer hub. The assembled unit is supplied e-beam sterile for single use. The device is delivered with the plug in the crimped state to the target vessel using a guidewire through a standard angiographic catheter. Upon deployment in the target vessel and exposure to an aqueous environment and body temperature, the plug will self-expand to embolize the target vessel. The anchor coil stabilizes the device within the vessel to allow precise control of placement and to minimize risk of device migration and unintended thromboembolism while the plug expands to embolize and conform to the vessel lumen.