Abiomed (NASDAQ: ABMD), a leading provider of breakthrough heart
support technologies, announces the 1,000th patient has been
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. Impella is a
minimally invasive therapy that takes over the pumping function of
the heart, pumping blood around the body while the heart rests and
recovers.
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The Impella 5.0 is a forward flow heart
pump that delivers up to 5 L/min, stabilizing a patient’s
hemodynamics, unloading the left ventricle and perfusing the end
organs, allowing for the potential of native heart recovery or
return to heart function baseline. (Photo: Business Wire)
The first patient in Japan was successfully treated in October
2017 with the Impella 5.0 heart pump 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. Since then, more than 100 hospitals across
Japan can now provide Impella support to patients and 138 hospitals
have been approved by the government and the Circulatory Support
Committee.
Of the first 1,000 Japanese cases, procedural outcomes data is
available on the first 580 cases1). The data demonstrates
improvements in AMI cardiogenic shock and myocarditis survival
rates during the procedure, compared to traditional therapies:
AMI Cardiogenic Shock:
- With Impella only (n=109):
- 87% survival to Impella explant with 97% heart recovery2)
- With Impella + percutaneous cardiopulmonary support (PCPS)
(n=89):
- 54% survival at explant and 75% heart recovery2)
- With PCPS only:
- 21% survival to discharge, according to the DPC Database3) and
31% survival to 30 days according to the JCS Shock Registry4)
Myocarditis:
- With Impella only and with Impella + percutaneous
cardiopulmonary support (PCPS) (n=62):
- 83% survival to Impella explant
- With PCPS only:
- 43% survival to discharge according to the DPC Database3)and
52% survival according to the Sawamura CHANGE PUMP Study5)
The protocols used to introduce Impella in Japan were developed
based on best practices learned from the experience treating
patients in Europe and the United States, including the National
Cardiogenic Shock Initiative, the Impella Quality (IQ) Database and
the cVAD Study.
According to Professor Sawa, "Since the first case was
implemented in October 2017, the number of patients treated with
Impella heart pump has been increasing steadily. In Japan, many
cardiologists understand the effectiveness of Impella as an
unprecedented new option for heart treatment and they are actively
working to introduce Impella in their hospitals. As a result, two
years after the first case, the number of sites which can provide
Impella treatment to the patient has reached more than 100
nationwide with better clinical outcomes6). I expect that the goal
of Impella therapy can not only contribute to saving lives, but to
heart recovery for more patients.”
“In the past two years we have accumulated clinical results
safely with rigorous training and education on best practice
protocols, which allowed us to achieve optimal results,” said Eizo
Nishimura, president of Abiomed Japan K.K. “Impella is a new option
to increase survival and heart recovery rate and turn circulatory
support into ‘therapy.’ I would like to thank all the healthcare
professionals for their efforts to deliver this innovative
technology to more than 1,000 patients. We will continue our effort
to make contributions to develop the field of heart recovery,
enabling many patients to recover their heart function and return
to their normal lives."
1) Interim tracking data provided by Abiomed Japan as of March
2019 2) Percentage of survival values at Impella removal without
the transfer to the circulatory assist device such as IAPB, PCPS
and VAD 3) Aso, Critical Care. 2016. 20:80 4) Ueki, PE-767. JCS2016
Poster Session 5) Sawamura, Circ J 2018; 82:699-707 6) O’Neill, AHJ
2018; 202:33-38
ABOUT IMPELLA 2.5 and 5.0 HEART PUMP IN JAPAN
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.
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 IN THE UNITED STATES AND
EUROPE
The Impella 2.5® and Impella CP® devices are U.S. FDA PMA
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. The Impella 2.5, Impella CP, Impella CP with
SmartAssist®, Impella 5.0®, Impella LD®, and Impella 5.5™ with
Smart Assist® are U.S. FDA approved heart pumps used to treat heart
attack or cardiomyopathy 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 RP® is
U.S. FDA approved to treat right heart failure or decompensation
following left ventricular assist device implantation, myocardial
infarction, heart transplant, or open-heart surgery. Impella is the
most studied mechanical circulatory support device in the history
of the FDA with real world clinical data on more than 100,000
patients and more than 550 peer-reviewed publications.
In Europe, the Impella 2.5, Impella CP and Impella CP with
SmartAssist are CE marked for treatment of high-risk PCI and AMI
cardiogenic shock patients for up to 5 days. Impella 5.0 and
Impella LD are CE marked to treat heart attack or cardiomyopathy
patients in cardiogenic shock for up to 10 days. The Impella 5.5™
with Smart Assist® is CE marked to treat heart attack or
cardiomyopathy patients in cardiogenic shock for up to 30 days. The
Impella RP is CE marked to treat right heart failure or
decompensation following left ventricular assist device
implantation, myocardial infarction, heart transplant, open-heart
surgery, or refractory ventricular arrhythmia.
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.impella.com.
ABOUT ABIOMED
Based in Danvers, Massachusetts, USA, 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.
Abiomed, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella
CP, Impella RP, and Impella Connect are registered trademarks of
Abiomed, Inc., and are registered in the U.S. and certain foreign
countries. Impella BTR, Impella 5.5, Impella ECP, CVAD Study, and
SmartAssist are pending trademarks of Abiomed, Inc.
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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version on businesswire.com: https://www.businesswire.com/news/home/20191007005168/en/
Tom Langford Director, Communications & Public Relations
978-882-8408 tlangford@abiomed.com
Ingrid Goldberg Ward Director, Investor Relations 978-646-1590
igoldberg@abiomed.com
Itsuki Shinohara (Abiomed Japan) Manager, Public Relations
81-3-4588-537 ishinohara@abiomed.com
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