Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough
heart support technologies, announced today that 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) for the treatment of
drug-resistant acute heart failure.
With this approval, these are the first and only percutaneous
temporary ventricular support devices that are PMDA-approved in
Japan deemed safe and effective in the indication, as stated:
This product is a catheter-styled blood pump, used for
drug-resistant acute heart failure, such as cardiogenic shock, to
support systemic circulation by placing the device at left
ventricle from a femoral artery insertion and expelling blood
directly from left ventricle to ascending aorta.
Acute heart failure is a sudden and temporary morbid state in
which various factors such as acute myocardial infarction, ischemic
heart disease and/or reduced cardiac function may prevent the
delivery of oxygen to the heart and other vital organs, resulting
in the rapid deterioration of heart function. In Japan, it is
estimated that 50,000 acute heart failure patient opportunities
exist in the country. In the United States, this patient population
is included in the high risk urgent PCI and cardiogenic shock
indications. The Japanese indication states that the pump can be
used for a duration determined by the physician based on the
clinical needs of the patient.
Japanese researchers and physicians have studied hemodynamic
science and heart recovery for decades and have been leaders in the
field for high-risk revascularization in the cath lab. Due to
cultural and quality of life expectations and an aging society,
Japan is the second largest medical device market in the world.
Percutaneous options for revascularization are preferred over
sternotomy or heart transplant alternatives because of the cultural
interest in treating patients minimally invasively. For chronic
heart failure patients, implantable LVAD devices or heart
transplant remain an option at very limited sites for patients that
do not have the ability to achieve native heart recovery.
Abiomed is opening a larger office in Tokyo, recruiting for
clinical support staff, and submitting for Japanese reimbursement
in the near future. A rigorous on-site training and certification
program is planned including physician proctoring. Abiomed plans to
start supporting patients in Japan during the fourth quarter of FY
’17 and will be investing in distribution, but does not expect
material revenue until FY ‘18 given the controlled roll-out.
Additionally, the Company is planning future discussions with the
PMDA relating to potential regulatory reviews of the Impella CP and
Impella RP later this fiscal year.
“This approval marks a significant milestone to provide Impella
hemodynamic support for heart failure patients. We commend the
dedication of Japanese physicians and regulatory bodies in
searching for new treatment options to improve patient outcomes and
quality of life, and enable cost-effective solutions,” said Michael
R. Minogue, President, Chairman and Chief Executive Officer of
Abiomed. “We are pleased that the field of heart recovery with
percutaneous heart pumps has begun in Japan.”
ABIOMED DATA SUPPORTING APPROVALImpella
clinical data supported an overall high safety profile and recovery
of acute heart failure with improved quality of life. The
supporting data includes an FDA study and randomized controlled
trial which demonstrated improvement in hemodynamics vs. IABP. The
company will conduct a post-market surveillance on Impella
usage.
ABOUT IMPELLAThe Impella
products offer the unique ability to stabilize the patient’s
hemodynamics and unload the heart, which allows the muscle to rest
and potentially recover its native function. Impella 2.5
received FDA PMA approval for high risk PCI in March 2015.
Impella 2.5, Impella CP, and Impella 5.0 received FDA PMA approval
for cardiogenic shock in the setting of acute myocardial
infarction/heart attack or after heart surgery. These are the first
and only percutaneous temporary ventricular support devices that
are FDA-approved as safe and effective for the cardiogenic shock
indication. The Impella product portfolio, which is comprised of
Impella 2.5, Impella CP, Impella 5.0, Impella LD, and Impella RP,
has supported over 40,000 patients in the United States.
The ABIOMED logo, ABIOMED, Impella, Impella CP,
and Impella RP are registered trademarks of Abiomed, Inc. in the
U.S.A. and certain foreign countries. Impella 2.5, Impella 5.0,
Impella LD, and Protected PCI are trademarks of Abiomed, Inc.
ABOUT ABIOMED Abiomed, Inc. based in Danvers,
Massachusetts, with offices in Tokyo, Japan, 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.
FORWARD-LOOKING STATEMENTS This release
includes forward-looking statements. These forward-looking
statements generally can be identified by the use of words such as
“anticipate,” “expect,” “plan,” “could,” “may,” “will,” “believe,”
“estimate,” “forecast,” “goal,” “project,” and other words of
similar meaning. These forward-looking statements address
various matters including, the Company’s guidance for fiscal 2016
revenue. Each forward-looking statement contained in this press
release is subject to risks and uncertainties that could cause
actual results to differ materially from those expressed or implied
by such statement. Applicable risks and uncertainties
include, among others, 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
the risks identified under the heading “Risk Factors” in the
Company's Annual Report on Form 10-K for the year ended March 31,
2015 and the Company’s Quarterly Report on Form 10-Q for the
quarter ended September 30, 2015, each filed with the Securities
and Exchange Commission, as well as other information the Company
files with the SEC. We caution investors not to place
considerable reliance on the forward-looking statements contained
in this press release. You are encouraged to read our filings
with the SEC, available at www.sec.gov, for a discussion of these
and other risks and uncertainties. The forward-looking
statements in this press release speak only as of the date of this
release and the Company undertakes no obligation to update or
revise any of these statements. Our business is subject to
substantial risks and uncertainties, including those referenced
above. Investors, potential investors, and others should give
careful consideration to these risks and uncertainties.
For more information, please contact:
Ingrid Goldberg
Director, Investor Relations
978-646-1590
ir@abiomed.com
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