Abiomed will initiate pivotal randomized
controlled trial with FDA
Abiomed (NASDAQ: ABMD) announces the results of the FDA STEMI
Door-to-Unloading safety and feasibility randomized controlled
trial, which show unloading the left ventricle with Impella CP® for
30 minutes prior to reperfusion in patients presenting with
anterior ST-segment elevation myocardial infarction (STEMI) without
cardiogenic shock is safe and feasible, when compared to Impella
patients reperfused immediately.
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The Impella CP heart pump, manufactured
by Abiomed, enables heart recovery. (Photo: Abiomed, Inc.)
The results of the prospective, 50 patient, randomized,
multi-center trial were presented today by Navin Kapur, MD,
executive director of the CardioVascular Center for Research and
Innovation at Tufts Medical Center, at the American Heart
Association Scientific Sessions 2018 in Chicago. They were
simultaneously published in Circulation. Dr. Kapur and William
O’Neill, MD, medical director of the Center for
Structural Heart Disease at Henry Ford
Hospital in Detroit are co-principle investigators of the
study.
The study found:
- Unloading first and delaying
reperfusion by 30 minutes did not increase 30-day major adverse
cardiovascular and cerebrovascular events (MACCE) or infarct size,
compared to the immediate reperfusion arm of the trial. Infarct
size is a measure of damage to the heart muscle after a heart
attack.
- It is feasible to delay reperfusion in
a heart attack (STEMI) patient in a clinical trial, as demonstrated
by a 100% adherence to the 30 minute unloading protocol and 100%
Impella CP insertion success in both study arms.
- Unloading the left ventricle for 30
minutes prior to reperfusion appears to reduce infarct size as a
percentage of area at risk among patients with a ST sum greater
than 6.
“If a reduction of infarct size from unloading before
reperfusion is confirmed in a future trial, this concept would
enhance the existing guidelines of immediate reperfusion for STEMI
patients,” said Dr. Kapur. “75 percent of patients experiencing
their first heart attack will develop heart failure within
five years, so new approaches are needed to reduce infarct size and
prevent heart failure. Pre-clinical non-human data sets show
unloading the left ventricle prior to reperfusion activates a
cardioprotective program that reduces reperfusion injury, and could
improve the current standard of care.”
Abiomed also announces that, in agreement with the FDA, it will
move forward with a pivotal, multi-center, prospective, randomized
controlled trial comparing unloading with delayed reperfusion to
the current standard of care (immediate reperfusion without
Impella). The pivotal trial is planned to begin next year.
“This safety and feasibility study gives us hope that we can
help STEMI heart attack patients in the future by unloading the
heart muscle with delayed revascularization. The planned pivotal
randomized controlled trial will further examine whether unloading
with Impella CP for 30 minutes prior to reperfusion will
potentially slow down or avoid the development of heart failure,”
said Dr. O’Neill.
“We would like to thank the FDA, our dedicated employees, the
patients who consented and all the investigators for their efforts
to successfully complete this milestone. We look forward to the
pivotal study and expanding the clinical science for the field of
heart recovery," said Michael R. Minogue, chairman, president, and
chief executive officer of Abiomed.
The safety and feasibility study design was approved by the FDA,
with an independent steering committee and data and safety monitor
overseeing the trial and a blinded clinical events committee
independently adjudicating study endpoints. Infarct size was
evaluated using a cardiac magnetic resonance imaging technique
assessed at a blinded core lab. The trial was sponsored by
Abiomed.
Impella® heart pumps are not FDA approved for use in STEMI
patients without cardiogenic shock.
Abiomed will discuss the trial results with investors during a
short call on Monday, November 12 at 8:00am EST. To listen to the
call live, please tune into the webcast via
http://investor.abiomed.com or dial (855) 212-2361. The
international number is (678) 809-1538. The access code is 808
3207.
BACKGROUND INFORMATION
STEMI is a type of heart attack caused by a blockage in one of
the main heart arteries, preventing the flow of oxygen to the
heart. It is estimated that 965,000 people a year have heart
attacks1, of which approximately 200,000 are classified as STEMI2.
The current standard of care is sometimes called Door-to-Balloon
"DTB", for the goal of minimizing the time it takes an
interventional cardiologist to deploy an angioplasty balloon to
open the patient’s blocked artery. The recommended treatment in
guidelines for STEMI is revascularization (opening the blocked
artery) to restore blood flow and oxygen supply to the heart muscle
through primary percutaneous coronary intervention (PCI) within 90
minutes or less from the time of first medical contact. Impella®
heart pumps are not FDA approved for use in STEMI patients without
cardiogenic shock.
ABOUT IMPELLA HEART PUMPS
The Impella 2.5 and Impella CP devices are FDA 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® and Impella LD® are 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. 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.
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.
1. "Heart Disease and Stroke Statistics 2016 Update: A Report
from the American Heart Association Statistics Committee and Stroke
Statistics Subcommittee." (Circulation. 2016; 133(4); 38-360).
2. "Recent Trends in the Incidence, Treatment, and Outcomes of
Patients with ST and Non-ST-Segment Acute Myocardial Infarction,"
(Am. J. Med. 2011; 124(1); 40—47).
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version on businesswire.com: https://www.businesswire.com/news/home/20181111005043/en/
AbiomedTom Langford, 978-882-8408Director, Communications and
Public Relationstlangford@abiomed.comorIngrid Goldberg Ward,
978-646-1590Director, Investor Relationsigoldberg@abiomed.com
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