ABBOTT PARK, Ill., Nov. 7, 2016
/PRNewswire/ -- Abbott (NYSE: ABT) announced today that the
Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the company's Absorb
bioresorbable heart stent, making the first-of-its-kind medical
device commercially available to treat people in Japan with coronary artery disease.
Absorb is the only fully dissolving heart stent approved in
Japan for the treatment of heart
disease, one of the leading causes of death in Japan and worldwide. An estimated 1.73
million2 people in Japan (population: 127 million) have heart
disease, and approximately 71.7 thousand3 people
die each year from coronary artery disease, making it the secondary
leading cause of death in the country annually. Worldwide, more
than 7.4 million people die of heart disease each
year.4
"Absorb has the potential to address the unsolved challenges of
managing coronary artery disease with conventional drug eluting
metallic stents," said Prof. Takeshi
Kimura, M.D., Ph.D., director of cardiovascular medicine at
Kyoto University Hospital in
Japan and the principal
investigator of ABSORB JAPAN, the
clinical study that led to the MHLW's approval of the device. "Our
research, which involved 400 patients at 38 Japanese sites, shows
that this fully dissolving stent delivered comparable results to
the best-in-class Abbott XIENCE® metallic
drug-eluting stent on clinically important measures of safety and
efficacy."
Japan ranks as the
second-largest single-country market for advanced medical
technology behind the United
States, where the U.S. Food and Drug Administration (FDA)
approved Absorb in July 2016.
While stents are traditionally made of metal, Abbott's Absorb
stent is made of a naturally dissolving material, similar to
dissolving sutures. Absorb disappears completely5 in
approximately three years, once it has done its job of keeping a
clogged artery open and promoting healing of the treated artery
segment. By contrast, metal stents are permanent implants that may
cause future blockages.
"We're very excited to bring the promise of Absorb to patients
in Japan," said Deepak Nath, Ph.D., senior vice president,
vascular, Abbott. "We believe the Absorb bioresorbable stent can
help people live better, healthier lives without the concern of a
having a metal implant."
Abbott's Absorb stent, sold commercially as the Absorb GT1
Bioresorbable Vascular Scaffold (BVS) system, has been used to
treat more than 150,0001 people in more than 100
countries around the world. Absorb was recently approved in
the United States and Canada.
About Abbott:
At Abbott, we're committed to helping you live your best possible
life through the power of health. For more than 125 years, we've
brought new products and technologies to the world — in nutrition,
diagnostics, medical devices and branded generic pharmaceuticals —
that create more possibilities for more people at all stages of
life. Today, 74,000 of us are working to help people live not just
longer, but better, in the more than 150 countries we serve.
Connect with us at www.abbott.com, on Facebook at
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@AbbottGlobal.
1 Based on worldwide device utilization rate. Data on
file at Abbott.
2 Ministry of Health, Labour and Welfare Japan, Patients
Survey 2014,
http://www.mhlw.go.jp/toukei/saikin/hw/kanja/14/index.html
3 Ministry of Health, Labour and Welfare Japan,
Population Survey Report vital statistics 2015:
http://www.mhlw.go.jp/toukei/saikin/hw/jinkou/kakutei15/index.html
4 World Health Organization
5 Absorb dissolves except for two pairs of tiny metallic
markers that remain in the artery to enable a physician to see
where the device was placed.
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