Abbott Initiates Randomized Clinical Trial in Japan to Evaluate the Absorb™
Bioresorbable Vascular Scaffold
ABBOTT PARK, Illinois, June 11, 2013
--Trial to Study the Innovative "Dissolving" Heart Device Compared to
Abbott's Market-Leading Drug Eluting Stents in Patients with Coronary Artery
Disease in Japan
ABBOTT PARK, Illinois, June 11, 2013 /PRNewswire/ --Abbott (NYSE: ABT) today
announced that it has initiated the ABSORB Japan randomized controlled
clinical trial to evaluate the Absorb™ Bioresorbable Vascular Scaffold (BVS)
in patients with coronary artery disease (CAD), the most common form of heart
disease. The results of this trial will support regulatory filings with the
Japanese Pharmaceutical and Medical Devices Agency (PMDA) for approval of
Absorb BVS in Japan.
The Absorb BVS, a drug eluting, fully bioresorbable vascular scaffold, is a
small mesh tube designed to open a blocked heart vessel, restore blood flow to
the heart and then dissolve into the vessel over time. Unlike a metallic
stent that remains permanently in the body, Absorb is referred to as a
scaffold to indicate that it is a temporary structure. Abbott's Absorb is made
of polylactide, a naturally dissolvable material that is commonly used in
medical implants such as dissolving sutures.
CAD is the leading cause of death in the world. In Japan, changes in diet
and lifestyle have raised concerns of a potential increase in heart
disease-related deaths. According to the World Health Organization (WHO),
cardiovascular disease is responsible for nearly one-third of all deaths in
ABSORB Japan will enroll approximately 400 patients and compare the
performance of Absorb to Abbott's market-leading XIENCE™ family of metallic
drug eluting stents. The primary endpoint is target lesion failure (TLF) at
one year, a combined measure of safety and efficacy of the device. Takeshi
Kimura, M.D., professor, Department of Cardiovascular Medicine, Kyoto
University Hospital, is the principal investigator of the ABSORB Japan trial.
"Unlike permanent metallic stents, Absorb dissolves over time, which may allow
the blood vessel to regain natural function, a unique effect that could have
significant impact on the way coronary artery disease is treated in Japan,"
said professor Kimura. "While the clinical outcomes of Absorb have been
demonstrated in international clinical trials, we now have the opportunity to
understand the impact of this technology in Japanese patients in a comparative
study, and hope the results of this effort support the process to make Absorb
widely available for clinical use in Japan in the future."
The trial also will incorporate state-of-the-art imaging techniques to study
the impact of treatment with Absorb in the blood vessel. The first patient in
ABSORB Japan was enrolled by Shigeru Saito, M.D., director, Cardiology and
Catheterization Laboratories, and vice president, Shonan Kamakura General
Hospital, Kanagawa, Japan, who also enrolled the first patient in the ABSORB
EXTEND trial in Japan – a prospective, single-arm trial initiated by Abbott in
January 2010 in Japan and other international markets, including Europe. Data
from the ABSORB EXTEND trial and other international trials have been
presented at major medical meetings and continue to support the near-term
safety and efficacy of Absorb across traditional measures typically used to
evaluate a drug eluting stent. Ongoing evaluation will continue in randomized
trials, such as ABSORB Japan, to understand the unique, long-term benefits of
a device that dissolves completely over time.
"The deliverability of this device during a procedure is similar to a
best-in-class drug eluting stent, which is important for treating blockages
with ease and confidence in a range of patients," said Dr. Saito. "We
anticipate continued, growing enthusiasm about Absorb from physicians and
patients. By leaving no permanent implant behind, this innovative device has
the potential to provide benefits never before seen with metallic stents."
Since the 1970s, physicians have treated patients with CAD with balloon
angioplasty and metallic and drug eluting metallic stents. Nearly a decade
ago, scientists at Abbott began development of Absorb. Now Abbott is the first
company in the world to begin a randomized clinical trial – the third in total
for the company – to test a drug eluting bioresorbable vascular scaffold in
patients in Japan. Abbott recently completed enrollment for ABSORB II, a
randomized trial initiated in Europe and New Zealand in November 2011.
"The initiation of ABSORB Japan represents the commitment of Abbott to invest
in building the body of data for Absorb to benefit physicians and patients in
Japan," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice
president, Medical Affairs, and chief medical officer, Abbott Vascular. "We
look forward to the knowledge gained during the course of this trial in Japan,
home to many of the world's pioneers in interventional cardiology, to learn
more about the potential of Absorb – the world's first drug eluting
bioresorbable vascular scaffold."
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
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.
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.
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.
 Coronary Artery Disease. National Heart, Lung and Blood Institute. May
2011 Available at: http://www.nhlbi.nih.gov/health/health-topics/topics/cad/
 Absorb 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.  The top 10 causes of death, World Health
Organization. June 2011 Available at:
http://www.who.int/mediacentre/factsheets/fs310/en/index.html  Iso, H.
(2011). Lifestyle and cardiovascular disease in Japan. Journal of
Atherosclerosis and Thrombosis, Retrieved from
http://www.ncbi.nlm.nih.gov/pubmed/21307610  World Health Organization
(n.d). The impact of chronic disease in Japan. Retrieved from
CAUTION: Investigational device. Limited by Federal (U.S.) law to
investigational use only.
Absorb is a trademark of the Abbott Group of Companies.
Contact: Media: Steve Kelly, +1-408-444-3018, or Financial: Tina Ventura,
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