Indications (US & Outside US)
The IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.
The IMPEDE Embolization Plug has received both FDA 510(k) clearance and CE mark.
The IMPEDE Embolization Plug consists of an anchor coil and 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.
The anchor coil enables implantation in arteries and veins and minimizes the risk of device migration.
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 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 Instructions for Use - US (Updated Nov 2018)
IMPEDE Instructions for Use - Outside US (Updated Apr 2019)
IMPEDE Brochure - US (New look coming soon, Jun 2019)
IMPEDE Brochure - Outside US (Updated Jan 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.