Cordis Neurovascular, Inc.
announced today that the U.S. Food and Drug Administration has granted
Humanitarian Device Exemption (HDE) approval for the CORDIS ENTERPRISE(TM)
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.
Cordis Neurovascular, Inc.
Cordis Neurovascular, Inc. develops, manufactures and markets medical
devices for neurovascular applications, including cerebral embolization
procedures
Cordis Neurovascular, Inc.
cordis