Abiomed Announces First Patient Treated with Impella® in Japan
October 26 2017 - 7:03AM
Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough
heart support technologies, announced today the first patient
treated with the Impella heart pump in Japan. The Impella
2.5
® and Impella 5.0
® heart pumps
are approved for the treatment of drug-resistant acute heart
failure and are the first and only percutaneous temporary
ventricular support devices Pharmaceuticals and Medical Devices
Agency (PMDA) approved in Japan.
The first patient in Japan was treated with the Impella 5.0
heart pump after suffering from acute heart failure. The patient
was treated at Osaka University Hospital under the leadership of
Professor Yoshiki Sawa, M.D., Ph.D. of the Department of
Cardiovascular Surgery, Osaka University’s Graduate School of
Medicine. According to Professor Sawa, “In acute heart
failure, such as cardiogenic shock, initial treatment is very
important because of its impact on subsequent cardiac functions and
the patient’s general condition. Impella, which provides
minimally invasively mechanical support for the circulatory system,
makes it possible to carry out safe and effective treatment even in
the case of severe heart failure, which had been difficult until
now. This is a very fortunate development for both patients and
their families, so we look forward to using Impella and supporting
its popularization in the medical field.”
Japanese researchers and physicians have studied hemodynamic
science and heart recovery for decades. Japan is the second largest
medical device market in the world and Japanese physicians have
been leaders in the field for high-risk revascularization in the
surgery suite and cath lab. In Japan, percutaneous options for
hemodynamic support are limited and Impella fills the need for a
more contemporary device that promotes heart recovery.
“Treating the first Japanese Impella patient marks a significant
milestone for our Company,” said Michael R. Minogue, President,
Chairman and Chief Executive Officer of Abiomed. “We are pleased to
launch the Field of Heart Recovery in Japan and we commend the
dedication of Japanese physicians and the regulatory body for
seeking out new and cost-effective solutions for improving patient
outcomes and quality of life."
The Impella 2.5 and Impella 5.0 heart pumps received
Pharmaceuticals and Medical Devices Agency (PMDA) approval from the
Japanese Ministry of Health, Labor & Welfare (MHLW) in
September 2016 and received reimbursement, effective September,
2017. Abiomed has opened an office in Tokyo and plans to launch at
10 Japanese hospitals by the end of the fiscal year, in March
2018.
IMPELLA 2.5 AND 5.0 HEART PUMP INDICATION IN
JAPAN
In Japan, the Impella heart pump is used for the following
indication: In the treatment of drug-resistant acute heart failure
attributable to causes such as cardiogenic shock, a catheter is
inserted percutaneously/transvascularly without chest-opening
surgery, and blood is aspirated via the tip of a catheter
inserted/placed into the left ventricle and pumped out via the
outlet port located in the ascending aorta, thereby assisting with
antegrade blood circulation in the body. It aims to improve
hemodynamics and the recovery of the heart muscles through prompt
assistance of antegrade blood flow in a minimally invasive manner
while reducing burden on the heart muscles, allowing for prompt
recovery of cardiac function.
ABOUT IMPELLA HEART PUMPS
The Impella 2.5®, Impella CP® and Impella 5.0® are FDA-approved
heart pumps used to treat heart attack patients in cardiogenic
shock, and have the unique ability to enable native heart recovery,
allowing patients to return home with their own heart. The Impella
2.5 and Impella CP devices are also approved to treat certain
advanced heart failure patients undergoing elective and urgent
percutaneous coronary interventions (PCI) such as stenting or
balloon angioplasty, to re-open blocked coronary arteries.
Abiomed's right-side heart pump, the Impella RP® device, is FDA
approved to treat patients experiencing acute right heart failure
or decompensation following left ventricular assist device
implantation, myocardial infarction, heart transplant, or
open-heart surgery. To learn more about the Impella platform of
heart pumps, including their approved indications and important
safety and risk information associated with the use of the devices,
please visit: www.protectedpci.com.
The ABIOMED logo, ABIOMED, Impella, Impella 2.5, Impella 5.0,
Impella LD, Impella CP, Impella RP, and Recovering Hearts. Saving
Lives. are registered trademarks of ABIOMED, Inc. in the U.S. and
in certain foreign countries.
ABOUT ABIOMED Based in Danvers,
Massachusetts, Abiomed, Inc. is a leading provider of medical
devices that provide circulatory support. Our products are
designed to enable the heart to rest by improving blood flow and/or
performing the pumping of the heart. For additional information,
please visit: www.abiomed.com.
**For further information please contact:
Ingrid Goldberg WardDirector, Investor
Relations978-646-1590igoldberg@abiomed.com
FORWARD-LOOKING STATEMENTS
This release contains forward-looking statements, including
statements regarding development of Abiomed's existing and new
products, the Company's progress toward commercial growth, and
future opportunities and expected regulatory approvals. The
Company's actual results may differ materially from those
anticipated in these forward-looking statements based upon a number
of factors, including uncertainties associated with development,
testing and related regulatory approvals, including the potential
for future losses, complex manufacturing, high quality
requirements, dependence on limited sources of supply, competition,
technological change, government regulation, litigation matters,
future capital needs and uncertainty of additional financing, and
other risks and challenges detailed in the Company's filings with
the Securities and Exchange Commission, including the most recently
filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q.
Readers are cautioned not to place undue reliance on any
forward-looking statements, which speak only as of the date of this
release. The Company undertakes no obligation to publicly release
the results of any revisions to these forward-looking statements
that may be made to reflect events or circumstances that occur
after the date of this release or to reflect the occurrence of
unanticipated events.
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