High Embolic Material Volume, Inherent High Packing Density

Vascular plugs predictably and effectively fill space in a short time, generally leading to shorter procedure times and less radiation exposure. Each IMPEDE-FX Embolization Plug offers a high embolic material volume and inherent 100% packing density. Packing density has been shown to be an important factor in avoiding recanalization.

Minimal Artifact

The shape memory polymer portion of the device has no artifact, which facilitates follow-up imaging. The images below are for illustrative purposes only since IMPEDE-FX may only be used in combination with IMPEDE.

Compatible IMPEDE - IMPEDE Embolization Plug

IMP-05

IMP-07 

IMP-10 

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 System is intended for use by physicians trained and experienced in embolization techniques, angiographic techniques, and interventional procedures. Standard techniques for placement of vascular access sheaths, catheter/sheath and guidewires should be employed.

• The safety and effectiveness of the IMPEDE-FX Embolization Plug has not been established for cardiac uses (e.g., cardiac septal occlusion, patent ductus arteriosus, paravalvular leak closure) or neurologic uses.

• Inspect the package and system prior to use. Do not use if the sterile package is open or damaged or if the system is damaged.

• Device is intended for single-use only. Do not attempt to re-process, re-sterilize, clean, or re-use the device. Improper sterilization and re-use can cause malfunction to the device and injury to the patient.

• Do not use a power injection syringe to inject contrast solution through the device.

• Do not use after the “Use-by” date specified on the package.

• Only physicians who have received appropriate training and who are familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with embolization and interventional procedures should use this device.

• Please note care in specific populations: pregnancy - care should be taken to minimize radiation exposure to the mother and fetus, and nursing mothers - there has been no quantitative assessment of the presence of leachables in breast milk.

Potential adverse events that may occur during or after a procedure include, but are not limited to:

• Air embolus

• Allergic reaction/toxic effects

• Bleeding

• Death

• Device migration

• Fever

• Foreign material embolic event

• Hematoma

• Hemolysis

• Infection

• Occlusion of unintended vessel

• Peripheral embolism

• Pulmonary embolism

• Recanalization

• Residual flow

• Stroke/TIA

• Surgical intervention

• Unintended thrombosis

• Vascular access site complication

• Vessel trauma/perforation