Abbott Initiates Clinical Trial of Absorb in the United States

Tue Jan 8, 2013 8:30am EST

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-  First-of-its-Kind Drug Eluting Bioresorbable Vascular Scaffold Now Being
Evaluated in U.S. Patients with Coronary Artery Disease
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 scaffold1, 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


Media: Jonathon Hamilton, +1-408-845-3491; Financial: Tina Ventura,
+1-847-935-9390
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