Indications (US Only)
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 has received FDA 510(k) clearance.
The IMPEDE-FX Embolization Plug consists of a biodegradable shape memory polymer (SMP) plug with a proximal marker band. The SMP is formulated to expand from its crimped shape when deployed into a blood vessel. The expanded polymer scaffold design provides an ideal structure for fast, stable, clot formation.
Fast, Stable, and Atraumatic Delivery and Occlusion – Innovative design enables quick, easy deployment, and vascular occlusion with low radial force and high vessel conformability, even in tortuous vessels.
Unique Mechanism of Action – SMP enables efficient clotting and integrative healing. Upon deployment of the SMP plug, thrombosis begins as a multitude of clots rapidly form within the polymer scaffold.
Easy Navigation – The IMPEDE-FX Embolization Plug advances through tortuous anatomy with limited friction, minimizing the potential of damaging blood vessels.
Promotes Healing – SMP has been proven effective in promoting collagen formation during advanced stages of healing in animal models.
Instructions for Use
IMPEDE-FX Instructions for Use - US Only (Updated Jun 2019)
IMPEDE-FX Brochure - US Only (New look coming soon, Jun 2019)
Federal (USA) law restricts these devices to sale, distribution and use by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.