St. Jude Medical Inc.
) has reached yet another important clinical landmark by
registering the first implant of its Amplatzer Cardiac Plug (ACP)
in a clinical trial. The ACP clinical study is intended to
evaluate the effectiveness of the device for the prevention of
left atrial appendage (LAA) stroke. The trial will enroll roughly
400 to 3,000 patients with atrial fibrillation (an uncontrolled
rate of heartbeat) across 90 centers in the U.S. and Canada.
Atrial fibrillation (AF) is the most common heart disease in
people above the age of 65 and up to 90% of the clots that form
in patients with AF originate from the LAA. Approximately 2.7
million Americans suffer from AF, according to the American Heart
Association. If left untreated, AF can lead to fatal consequences
and is responsible for about 20% of all ischemic strokes.
The minimally-invasive self-expanding transcatheter ACP device
from St. Jude's cardiovascular product line is used to seal off
the opening of the LAA in patients ailing from non-valvular AF.
The device is CE marked and has been the market leader since its
launch in 2008. The clinical trial should provide further
evidence that the device is superior to traditional medical
treatments and will help St. Jude to receive approval from the
Food and Drug Administration (FDA) for launching the product in
In Jan 2013, STJ had received CE Mark approval for its
advanced Amulet cardiovascular device, which is a notch above the
original ACP. It has been developed with suggestions from
physicians, who have already used the ACP in Europe and can be
used to treat a wider range of appendage anatomies. Following the
success of the ACP, the Amulet device should further boost
structural heart devices sales.
The medical technologies giant remains committed to develop
innovative offerings in the field of stroke care as it has huge
market opportunity in this area. As per the World Health
Organization (WHO), strokes occur in approximately 15 million
people across the globe every year, rendering it to be one of the
leading causes of death and long-term disability.
St. Jude currently has a Zacks Rank #3 (Hold).
Edwards Lifesciences Corp.
), which also manufactures transcatheter heart valves, currently
carries a Zacks Rank #2 (Buy).
While we remain on the sidelines regarding St. Jude due to
softness in the core Cardiac Rhythm Management ("CRM") business,
medical products companies such as
), which carry a Zacks Rank #2 (Buy), appear impressive.
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