AGA Medical Corporation today
announced that it has enrolled the first patients in its PREMIUM clinical
trial, a study examining the connections between certain types of migraine
headaches and a heart defect found in more than 20 percent of all adults.
The first patient was enrolled at Abbott Northwestern Hospital.
The PREMIUM (Prospective Randomized investigation to Evaluate the
incidence of headache reduction in subjects with Migraine and PFO Using the
AMPLATZER(R) PFO Occluder compared to Medical Management) trial is a
prospective, randomized, two-arm, double blind multi-center trial in the
U.S. to determine whether patients who undergo closure of a PFO with an
AMPLATZER(R) device have a reduction in both the frequency and severity of
migraine headaches. The study is expected to enroll approximately 400
patients at up to 35 medical centers.
Patent foramen ovale or PFO (pronounced "pay-tent for-ay-men
oh-volley") is a heart defect found in more than 20 percent of adults. A
PFO is a small flap-like opening between the upper chambers of the heart.
This opening is normal in fetuses but usually closes shortly after birth.
When it remains open, or "patent," it allows blood to bypass the filtering
system of the lungs. Substances such as very small blood clots or chemicals
in this unfiltered, non-regenerated blood traveling directly to the brain
may trigger migraine attacks.
More than 28 million people in the United States, about 11 percent of
the population, suffer migraine headaches. Recent observational studies
have reported that a significant number of patients experience a reduction
in the frequency and severity of migraine headaches following closure of
the PFO.
"We are pleased and excited to enroll the first patient in the PREMIUM
clinical trial," said Dr. Ronald Tarrel, a neurologist at the Noran
Neurological Clinic in Minneapolis, MN and Co-Director of the Stroke
Services Program at Abbott Northwestern Hospital. "PREMIUM has the
potential to yield important new information on the link between migraine
and a PFO. If successful, PFO closure could represent an important new
method of relief from migraine headaches for many migraine sufferers."
The AMPLATZER(R) PFO Occluder offers a less-invasive alternative to
open heart surgery for closing a PFO. The device is implanted via a
catheter inserted in the patient's groin. The procedure typically takes as
little as 15 minutes among experienced physicians, and the patient can
resume a normal lifestyle in about 24 hours.
PREMIUM is one of two AGA Medical sponsored studies exploring the link
between PFO holes and certain types of Migraine headaches. The PRIMA study
is already underway at sites in Europe and Canada.
"The PRIMA and PREMIUM studies represent significant opportunities to
further expand AGA Medical's well established worldwide leadership position
in the transcatheter closure of structural heart defects," said Franck
Gougeon, CEO of AGA Medical. "AGA is pleased to be working with leading
neurologists, headache specialists and cardiologists throughout the United
States, Europe and Canada. Through our active, ongoing collaboration with
these leaders in their respective fields, we have designed a protocol that
we believe can provide a definitive answer on the relationship between PFO
closure and reduction in the frequency and severity of certain types of
migraine headaches."
ABOUT AGA MEDICAL:
AGA Medical Corporation, based in Golden Valley, Minnesota (just outside Minneapolis) is the leader in developing interventional devices to treat structural heart defects. As a result of
the many contributions and creative genius of Dr. Kurt Amplatz, the Company
has developed and commercializes a series of devices that have
revolutionized the treatment of the most common congenital "holes in the
heart" such as atrial septal and patent foramen ovale defects. Over 500
articles have been published in peer reviewed medical publications that
support the benefits of AGA Medical devices including improved patient
outcomes, reduced length of stay and accelerated recovery times for the
patient. AGA Medical devices have received regulatory approval and are
marketed in over 90 countries with over 190,000 devices shipped to date.
For more information visit amplatzer
AGA Medical Corporation
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