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News Center
Reconstruction Stent Treats Intracranial Aneurysms
A new vascular reconstruction device and delivery system device is a self- expanding, closed-ell design, nitinol stent with good visible proximal and distal markers, and the added feature of a horizontal longitudinal marker on the delivery wire to facilitate delivery.
The enterprise vascular reconstruction device has been granted humanitarian device exemption (HDE) by the U.S. Food and Drug Administration (FDA) to treat intracranial aneurysms.
Pre-loaded onto a delivery system composed of an introducer and delivery wire for a simple system configuration, the device enables physicians to recapture the stent, and three radiopaque zones facilitate placement and visibility. The flexible closed-cell design is conformable and provides true vessel reconstruction at the neck of the aneurysm and an advanced scaffold for coil mass support.
The device is intended for use in patients with hard-to-treat aneurysms selected for endovascular neurointervention, an alternative procedure to neurosurgical clipping. The HDE has been approved to treat wide-neck, intracranial, saccular, or fusiform aneurysms arising from a parent vessel with a diameter of greater than or equal to 3 mm and less than or equal to 4 mm. In the interventional procedure, coils--implantable medical devices made of long strands of very thin, coiled platinum wire--are used to fill aneurysms to facilitate clot formation and occlude blood flow to reduce the risk of aneurysm rupture. The enterprise vascular reconstruction device, made by Cordis Neurovascular (Miami Lakes, FL, USA), acts as a scaffold to hold the coils in place inside some types of aneurysms that are difficult to treat with coils alone.
Complex intracranial aneurysms are extremely difficult to treat and it is important for physicians to have a broad array of options to address these rare and difficult cases, said Sam M. Liang, vice president of Cordis Neurovascular. We're pleased that Cordis is able to provide another important advancement in the treatment of aneurysms.
A HDE device is a medical device that is intended to benefit patients in the treatment or diagnosis of diseases or conditions that affect or is manifested in fewer than 4,000 individuals in the United States per year.
