- More Than 100,000 People with Coronary Artery Disease Have
Been Treated with Absorb
- Abbott on Track to Submit for Regulatory Approvals of
Absorb in the U.S., Japan and
China
PARIS, May 19, 2015 /PRNewswire/ -- Abbott
announced today that it has received CE Mark for the latest
advancement of its Absorb stent system, called Absorb GT1™, which
combines the world's first fully dissolving stent with a
next-generation delivery catheter to help doctors treat people with
heart disease. Built upon three generations of delivery catheter
innovations, Absorb GT1 refers to the GlideTrack catheter, Abbott's
most advanced stent delivery system, which is designed to make it
easier for doctors to access and treat diseased vessels in people
with coronary artery disease (CAD). The GlideTrack catheter
incorporates several design and technology changes that have the
potential to improve deliverability and performance.
Experience the interactive Multimedia News Release here:
http://www.multivu.com/players/English/7519551-abbott-vascular-absorb-gt1-ce-mark/
Photo - http://photos.prnewswire.com/prnh/20150519/216966
"Absorb GT1 will enable physicians to treat more people with
coronary artery disease due to its improved delivery system," said
Christoph Kurt Naber, director of
Contilia Heart and Vascular Centre, Essen, Germany. "Dissolving stents are the
next logical step in the treatment of patients with coronary artery
disease as these stents completely dissolve after opening up
clogged arteries and restoring blood flow. With the prevalence of
CAD around the world, this therapy has the potential to improve the
health of many people."
Last year, Abbott announced positive one-year clinical results
from ABSORB II, the world's first prospective, randomized,
controlled trial comparing the safety and effectiveness of the
fully dissolving Absorb heart device to Abbott's market-leading,
metallic XIENCE family of drug eluting stents. At one year,
overall clinical outcomes for Absorb were comparable to XIENCE. The
trial, conducted primarily in Europe, included 501 people with
CAD. At EuroPCR, a scientific meeting for cardiologists held in
Paris, Absorb data will be
presented throughout the conference, which runs from May 19-21, 2015. EuroPCR is the official
congress of the European Association of Percutaneous Cardiovascular
Interventions, with the goal of reducing the burden of
cardiovascular disease.
"Coronary artery disease is the most common disease in developed
countries, and the new Absorb GT1 catheter delivery system may
improve the ability of doctors to treat more people with CAD by
opening up coronary blockages in hard-to-reach areas with this
novel, fully dissolving stent," said Charles Simonton, M.D., FACC, FSCAI, chief
medical officer and divisional vice president, Medical Affairs,
vascular, Abbott. "Abbott is committed to developing scientific and
technological innovations that help people regain their health and
get back to their lives, and this latest Absorb advancement will
allow more people to benefit from this breakthrough medical
technology."
Absorb is currently available in more than 70 countries
worldwide. The company recently completed its submission for
regulatory approval of Absorb in Japan, and it plans to submit reports,
including data from pivotal trials, for regulatory approvals in
the United States and China in the coming months. Combined, these
three countries represent more than 50 percent of the world's heart
stent procedures. Currently, Absorb is an investigational device in
the U.S. and is not approved for U.S. commercial use.
About the Absorb Bioresorbable Vascular Scaffold
(BVS)
Absorb is a first-of-its-kind device that functions like a
metallic stent by opening a blocked artery in the heart and
restoring blood flow. However, unlike a metallic stent, which cages
the vessel, Absorb is more flexible and dissolves over time,
leaving behind a treated vessel free of a permanent implant with
the potential to flex, pulse and dilate in response to various
demands on the heart, based on people's lifestyle and activities,
such as exercise.[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.
About Coronary Artery Disease
Heart disease is the
leading cause of death for men and women around the world, and
coronary artery disease is the most common type of heart
disease.[3],[4] Coronary artery disease occurs when
arteries that supply blood to the heart become narrowed or blocked
due to plaque buildup, leading to chest pain or shortness of breath
and increased risk of heart attack.
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 73,000 people.
Visit Abbott at www.abbott.com and connect with us on Twitter at
@AbbottNews.
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Abbott
Media:
Steve Kelly,
(408) 845-3427
Mira Jang,
(408) 250-5782
Abbott
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Tina Ventura,
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[1] Absorb 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.
[2] Preliminary evidence suggests that natural vessel function
is possible with Absorb and may improve long term outcomes.
[3] The top 10 causes of death, World Health Organization. June
2011
Available
at: http://www.who.int/mediacentre/factsheets/fs310/en/index.html
[4] Coronary Artery Disease. National Heart, Lung and Blood
Institute. May 2011
Available
at: http://www.nhlbi.nih.gov/health/health-topics/topics/cad/