The WIRION® is an embolic protection device for use in stenting procedures. The system is intended for use in the cardiovascular intervention including carotid stenting procedures.
What is a Carotid Stenosis?
The carotid artery is the large artery whose pulse can be felt on both sides of the neck under the jaw. At the throat it forks into the internal and external carotid arteries. The internal carotid artery supplies the brain, and the external carotid artery supplies the face. This fork is a common site for atherosclerosis, an inflammatory buildup of atheromatous plaque that can narrow the lumen of the common or internal carotid arteries. The plaque can be stable and asymptomatic, or it can be a source of embolization. Emboli break off from the plaque and travel through the circulation to blood vessels in the brain. As the vessel gets smaller, they can lodge in the vessel wall and restrict blood flow to parts of the brain which that vessel supplies. This ischemia can either be temporary, yielding a transient ischemic attack, or permanent resulting in a thromboembolic stroke. Clinically, risk of stroke from carotid stenosis is evaluated by the presence or absence of symptoms and the degree of stenosis on imaging.
Carotid Stenting procedure is a minimally invasive therapy used in the treatment of Carotid Stenosis. Carotid artery stenting is a procedure in which your vascular surgeon inserts a slender, metal-mesh tube, called a stent, which expands inside your carotid artery to increase blood flow in areas blocked by plaque.
Embolic protection devices are used to capture and remove debris that becomes dislodged during an interventional procedure. Embolic debris may block smaller vessels, resulting in procedural complications or poor patient outcomes. While the risk of complications associated with embolic debris exists during all types of interventional procedures, patients with complex conditions such as critical limb ischemia, single vessel runoff or complex lesions (such as calcium or thrombus) face even greater risk.
As opposed to stenting/catheterization procedures which are interventional the Endarterectomy procedure is an open surgery.
During the procedure, a small incision is made in the neck below the jaw to expose the carotid artery. Blood that normally flows through the artery must be diverted in order to perform the surgery. This is accomplished by rerouting the blood through a tube (shunt) connecting the vessels below and above the surgical site. The carotid artery is opened and the waxy fat deposit is removed, sometimes in one piece. If the carotid artery is observed to be too narrow or too damaged to perform the critical job of delivering blood to the brain, a graft using a vein from the patient's leg may be created and stitched (grafted) onto the artery to enlarge or repair it. The shunt is then removed, and incisions in the blood vessels, the carotid artery, and the skin are closed.
The endarterectomy procedure takes about an hour to perform. General anesthesia is usually administered. A vascular surgeon or neurosurgeon will usually perform the surgery.