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Abbott Initiates Clinical Trial of Absorb™ in the United States



       Abbott Initiates Clinical Trial of Absorb™ in the United States

- First-of-its-Kind Drug Eluting Bioresorbable Vascular Scaffold Now Being
Evaluated in U.S. Patients with Coronary Artery Disease

- Study Will Compare the Innovative Absorb Device to the World's Leading
Metallic Drug Eluting Stent in a Head-to-Head Trial

PR Newswire

ABBOTT PARK, Ill., Jan. 8, 2013

ABBOTT PARK, Ill., Jan. 8, 2013 /PRNewswire/ -- Abbott (NYSE: ABT) announced
today the initiation of the ABSORB III clinical trial in patients in the
United States. This randomized, controlled trial is designed to enroll
approximately 2,250 patients, the majority in the United States, and compare
the performance of Abbott's drug eluting Absorb^™ Bioresorbable Vascular
Scaffold (BVS) device to the company's XIENCE^™ family of drug eluting stents.
The start of this trial in the United States follows the recent international
commercial launch of Absorb in Europe and parts of Latin America and Asia,
including the recent regulatory approval and launch in India – a country with
a significant and growing prevalence of heart disease. Data from the ABSORB
III trial will support U.S. regulatory filings for Absorb.

Absorb, a drug eluting, fully bioresorbable vascular scaffold^1, is an
innovative device for the treatment of coronary artery disease, which is a
narrowing of one or more arteries that supply blood to the heart. Absorb is
made of polylactide, a naturally dissolvable material that is commonly used in
medical implants such as dissolving sutures. Absorb works by opening a clogged
vessel and restoring blood flow to the heart similar to a drug eluting
metallic stent, the current standard of care. Absorb then dissolves into the
blood vessel, leaving behind a treated vessel that may resume more natural
function and movement because it is free of a permanent metallic implant.^1,2 

Dean Kereiakes, M.D., FACC, FSCAI, medical director of The Christ Hospital
Heart & Vascular Center and the Lindner Research Center in Cincinnati, and
professor of clinical medicine at Ohio State University, was one of the first
physicians to enroll a patient into the ABSORB III trial. "The deliverability
of the Absorb device is impressive and similar to a best-in-class drug eluting
stent," said Dr. Kereiakes, who is a co-primary investigator of the ABSORB III
trial. "Absorb combines the unique attributes of a dissolvable material with
the established MULTI-LINK stent design, making the scaffold flexible and
conformable to the vessel."

The ABSORB III clinical trial is designed to evaluate potential benefits of
Absorb in patients with coronary artery disease. Unlike a permanent metallic
stent, preliminary evidence of natural vessel function suggests that treatment
with an Absorb BVS could provide important clinical benefits.

"With the introduction of balloon angioplasty in the 1970s, cardiologists
wanted to open a blocked vessel without leaving anything behind. Absorb
represents the latest innovation that may help us reach this goal, which could
result in important long-term benefits related to the restoration of natural
vessel function," said Stephen Ellis, M.D., section head of Interventional
Cardiology at the Cleveland Clinic and co-primary investigator of the ABSORB
III trial. "The data collected on Absorb from the ABSORB III trial could have
the potential to drive significant changes in how cardiologists treat patients
with coronary artery disease."

The primary endpoint of ABSORB III is target lesion failure, a combined
measure of safety and efficacy, at one year. In addition, a subset of patients
within the trial will be evaluated for novel endpoints such as vasomotion, a
measure of how much natural motion returns to the vessel as Absorb dissolves
into the arterial tissue.

"Absorb is an excellent demonstration of Abbott's continued global leadership
and innovation. The ABSORB III trial will provide important insight about the
benefits of Absorb in U.S. patients with heart disease and will supplement the
knowledge gained about this technology since the start of international
clinical trials of Absorb in 2006," said Charles A. Simonton, M.D., FACC,
FSCAI, divisional vice president, Medical Affairs, and chief medical officer,
Abbott Vascular. "The advancement of Absorb into clinical trials in the United
States represents an important step in the process of filing for U.S.
regulatory approval – with the goal of establishing Absorb as a new
therapeutic option to treat U.S. patients with heart disease, the number one
killer of men and women."

About the Absorb Bioresorbable Vascular Scaffold
The Absorb Bioresorbable Vascular Scaffold, similar to a small mesh tube, is
designed to open a blocked heart vessel and restore blood flow to the heart.
Absorb is referred to as a scaffold to indicate that it is a temporary
structure, unlike a metallic stent, which is a permanent implant. The scaffold
provides support to the vessel until the artery can stay open on its own, and
then dissolves naturally over time. Absorb leaves patients with a vessel free
of a permanent metallic implant and may allow the vessel to resume more
natural function and movement, potentially providing long-term benefits.^1,2 

Abbott's BVS delivers everolimus, an anti-proliferative drug used in Abbott's
XIENCE coronary stent systems. Everolimus was developed by Novartis Pharma AG
and is licensed to Abbott by Novartis for use on its drug eluting vascular
devices. Everolimus has been shown to inhibit in-stent neointimal growth in
the coronary vessels following stent or scaffold implantation.

Approximately 1,000 patients from more than 20 countries have been treated
with the Absorb BVS device across multiple clinical trials, with data out to
five years on the first patients treated.

Absorb is an investigational device, limited by United States law to
investigational use and is not approved or available for sale in the United
States. Absorb is authorized for sale in CE Mark countries. Absorb is
available in Europe, the Middle East, parts of Latin America, and parts of
Asia Pacific, including India, Hong Kong, Malaysia and New Zealand.

The MULTI-LINK stent design includes MULTI-LINK VISION^®, XIENCE V^®, XIENCE
PRIME^® and, most recently, XIENCE Xpedition^™. More than 11 million implants
of the MULTI-LINK platform have occurred worldwide.

About Abbott Vascular
Abbott Vascular is the world's leader in drug eluting stents. Abbott Vascular
has an industry-leading pipeline and a comprehensive portfolio of
market-leading products for cardiac and vascular care, including products for
coronary artery disease, vessel closure, endovascular disease and structural
heart disease.

About Abbott
Abbott is a global healthcare company devoted to improving life through the
development of products and technologies that span the breadth of healthcare.
With a portfolio of leading, science-based offerings in diagnostics, medical
devices, nutritionals and branded generic pharmaceuticals, Abbott serves
people in more than 150 countries and employs approximately 70,000 people.

Visit Abbott at www.abbott.com and connect with us on Twitter at @AbbottNews.

^1Absorb completely dissolves except for two pairs of tiny metallic markers,
which help guide placement and remain in the artery to enable a physician to
see where the device was placed.

^2Preliminary evidence suggests that natural vessel function is possible and
may improve long term outcomes. Absorb is a trademark of the Abbott Group of
Companies. 

SOURCE Abbott

Website: http://www.abbott.com
Contact: Media: Jonathon Hamilton, +1-408-845-3491; Financial: Tina Ventura,
+1-847-935-9390
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