New Cordis device granted Humanitarian Exemption to treat intracranial aneurysms

Cordis Neurovascular, Inc. has announced that the U.S. Food and Drug Administration has granted Humanitarian Device Exemption (HDE) approval for the CORDIS ENTERPRISE Vascular Reconstruction Device and Delivery System for use with embolic coils in the treatment of wide-neck intracranial aneurysms.

An intracranial aneurysm is a weakness in the wall of a blood vessel in the brain that balloons out, forming a thin-walled bubble or sac. Approximately 30,000 intracranial aneurysms present annually. Some 15,000 patients are treated and up to 4,000 of these individuals are likely to need vascular reconstruction. Hemorrhagic stroke occurs when a cerebral aneurysm bursts and bleeds into brain tissue. In the U.S., stroke is the third leading cause of death, behind heart disease and cancer. Each year, about 700,000 people suffer a stroke according to the American Heart Association.

The CORDIS ENTERPRISE(TM) Vascular Reconstruction Device is available in the U.S. for use in patients with hard-to-treat aneurysms selected for endovascular neurointervention, an alternative procedure to neurosurgical clipping. Specifically, the stent is 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. Typically, in an 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. Some types of aneurysms are difficult to treat with coils alone, in which case an implantable assist device such as a stent may be used. The stent acts as a scaffold to hold the coils in place inside the aneurysm.

Dr. Michel Mawad, Chairman of Radiology at Baylor College of Medicine in Houston and Investigator in the U.S. clinical trial, said "The CORDIS ENTERPRISE(TM) Vascular Reconstruction Device is an important advancement in neuro-stent technology. It is very stable and flexible, and I am hopeful this stent will help us treat more difficult aneurysms."

The CORDIS ENTERPRISE(TM) Vascular Reconstruction Device is a new self- expanding, closed cell design, nitinol stent with good visible proximal and distal markers and an added feature of a horizontal longitudinal marker on the delivery wire to facilitate delivery. Pre-loaded onto a delivery system composed of an introducer and delivery wire for a simple system configuration, the CORDIS ENTERPRISE(TM) Vascular Reconstruction Device enables physicians to recapture the stent, and three radiopaque zones facilitate placement and visibility. The unique and flexible closed cell design is conformable and provides true vessel reconstruction at the neck of the aneurysm and an advanced scaffold for excellent coil mass support.

Sam M. Liang, Vice President, Cordis Neurovascular, Inc. said, "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. We're pleased that Cordis is able to provide another important advancement in the treatment of aneurysms."

A Humanitarian Device Exemption is an application that is similar to a pre-market approval (PMA) application, but exempt from the effectiveness requirements of a PMA. An approved HDE authorizes marketing of a Humanitarian Use Device. A Humanitarian Use 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 4000 individuals in the United States per year.

The clinical outcomes from the CORDIS ENTERPRISE(TM) Vascular Reconstruction Device Study, involving patients in Europe and the U.S., were assessed by an independent core lab, establishing a new standard for clinical evidence in the treatment of intracranial aneurysms. Data from the independently evaluated clinical study suggest that the CORDIS ENTERPRISE(TM) Vascular Reconstruction Device is a promising assist device for the treatment of aneurysms. The effectiveness of the device for this use has not been demonstrated.