FDA Approves Second
Medtronic Stent Graft for Minimally-Invasive Treatment of Aortic
Disease OK for Talent™ Thoracic
Stent Graft Follows April Approval of Talent™ Abdominal Stent
Graft; Both Systems Give Patients Access to Life-Saving Therapy that Avoids Open Surgery
June 7, 2008 -- Medtronic,
Inc. (NYSE: MDT) has announced their latest FDA approval for
an endovascular device:
the Talent™ Thoracic Stent Graft.
Talent™ Thoracic
Stent Graft
The
approval marks the second stent graft approval for Medtronic
in as many months: on April 16, the FDA okayed the company's
Talent Abdominal Stent Graft.
Both devices allow patients to
benefit from a minimally invasive treatment for certain types
of aneurysms of the aorta.
An aortic aneurysm occurs at a weakened segment
of the aorta, the body's main artery. Due the the pressure of the
blood flow, the weakened vessel wall begins expanding and ultimately
over time may rupture, often
a
fatal event.
For
decades, repair of an aortic aneurysm required a significant "open"
surgical procedure, due to the location of the aorta which is underneath
many other anatomic structures and organs. The aorta would be isolated,
the aneurysmal sack often excised, and an artificial graft sewn
into place. One of the problems with this procedure was that many
patients suffering from aortic aneurysms are elderly, often with
co-morbidities that
made such an invasive open surgical procedure risky, if not impossible.
In the 1990s,
the concept of repairing these aneurysms from the inside
out became a reality, due to the advancements of stent technology
and the imagination of pioneering surgeons, radiologists
and cardiologists. Argentinean surgeon Dr. Juan Parodi collaborated
with his
fellow countryman Dr. Julio Palmaz (co-inventor of the Palmaz-Schatz
coronary stent)
who was at the University of Texas Health Science Center
in San Antonio, and ultimately developed the first successful
AAA
endograft
device. (See
video clip from Angioplasty.Org's documentary,
"Vascular Pioneers: Evolution of a Specialty --
you can also buy
the DVD online.)
Parodi utilized
the concept of the body's
circulation
as
a "highway" for
the delivery of therapy (first used in angioplasty to open
blocked
arteries
with a balloon). He threaded his stent graft into the body
in much the same way as an angioplasty, through the femoral
artery in the leg
and then up into the aorta. The stent graft was expanded
inside of the aneurysmal segment, providing a new "pipe"
for the blood
to flow through.
The First
Endovascular AAA Repair, from the documentary,
"Vascular Pioneers: Evolution of a Specialty" (6:22)
Although there was much resistance to this new
technique in the beginning, over the past decade this technology
has advanced
to the point where endovascular treatment of aortic aneurysms is
now considered equivalent of the "gold standard" of surgery
for many patient populations, and the only treatment for those
patients who cannot tolerate surgery.
Medtronic was one of the early manufacturers
of this technology. Information from their press release, announcing
the FDA approval, follows.
Thoracic aneurysms affect
10 out
of
every 100,000
elderly Americans, and
data suggest
that the rate of this condition is increasing steadily.
While an estimated 60,000 Americans have a thoracic aortic aneurysm,
only about half are ever diagnosed due to lack of symptoms. The
rupture of an undiagnosed aneurysm or weakness of the thoracic
aorta is frequently
fatal. More common among smokers, the condition often results from
hardening of the arteries, hypertension or congenital disorders
such as Marfan’s syndrome.
"There are still many patients undiagnosed and in need of treatment
for thoracic aortic disease,” said Dr. Ronald Fairman, professor of Surgery and
chief of Vascular Surgery at the University of Pennsylvania Hospital. “FDA approval
of the Talent Thoracic Stent Graft is an important development in physicians’ abilities
to treat this life-threatening condition. In my own experience, this device offers
a superior alternative to open surgery and will allow physicians to perform minimally-invasive
thoracic aortic aneurysm repair for a broader population of patients.”
The Talent Thoracic Stent Graft System makes thoracic endovascular
aortic repair (TEVAR) accessible to an additional 25 percent of patients,
because of its unique features. It is available in the widest range
of diameters – from 22 mm to 46 mm. This size matrix offers physicians
multiple options to customize devices for their patients’ needs and
to treat a wider range of anatomies than with the other available
endografts.
Clinically Proven Safety and Efficacy
The Medtronic-sponsored Investigational Device Exemption (IDE) study
of the Talent Thoracic Stent Graft System is called the VALOR clinical
trial and enrolled 195 subjects at 38 medical centers between December
2003 and June 2005. All 195 patients received a Talent Thoracic Stent
Graft, and their outcomes were compared to 189 open surgical control
patients at three centers of excellence who matched selected inclusion/exclusion
criteria of the VALOR trial. Dr. Fairman served as VALOR’s principal
investigator.
The Talent Thoracic Stent Graft System Test Group met its primary
safety and efficacy endpoints, with an all-cause mortality of 16.1
percent and a successful aneurysm treatment rate of 89.2 percent
at 12 months. In the VALOR trial, 30-day mortality was 2.1 percent
and aneurysm-related mortality at 12 months was 3.1 percent. The
VALOR data show that endovascular therapy with the Talent Thoracic
Stent Graft results in lower mortality than open surgery, as well
as low rates of morbidity and device-related adverse events.
Leading Product Portfolio Broadens
In mid-April, Medtronic received FDA approval for the Talent Abdominal
Stent Graft for endovascular aortic repair (EVAR) of abdominal aortic
aneurysms. Both the Talent Abdominal and Thoracic devices represent
new options for many U.S. patients with aortic disease that would
otherwise require open surgery. They further broaden the leading
portfolio of endovascular stent grafts in the medical technology
industry.
"Each year there are at least 15,000 preventable deaths in the Unites States
due to aortic weakness and rupture,” said Tony Semedo, vice president and general
manager of the Endovascular Innovations business at Medtronic. “Medtronic began
laying the foundation of minimally-invasive treatment in the mid-1990s and remains
committed to leadership in this field, which seeks to improve outcomes for patients
with aortic aneurysms and related conditions. We have the broadest stent graft
portfolio, and are working diligently to ensure that patients who would benefit
from a minimally-invasive treatment have access to these life-saving devices.”
As a pioneer of endovascular therapy, Medtronic has been an innovator
and leader in the aortic stent graft industry for more than a decade.
Its long history includes
more than 130,000 patients treated with stent grafts dating back to 1995. Medtronic
currently offers the broadest portfolio of aortic stent grafts in the industry.
These include the Talent Abdominal and Thoracic Stent Graft Systems worldwide,
the AneuRx AAAdvantage® Abdominal Stent Graft System in the United States, and
the Valiant® Thoracic Stent Graft System outside the United States.
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis,
is the global leader in medical technology – alleviating pain, restoring
health, and extending life for millions of people around the world. Any forward-looking statements are subject to
risks and uncertainties such as those described in Medtronic’s Annual
Report on Form 10-K for the year ended April 27, 2007. Actual results
may differ materially from anticipated results. Source: Medtronic,
Inc. with additional reporting by Burt Cohen
of Angioplasty.Org