Abiomed will initiate pivotal randomized controlled trial with FDA
CHICAGO--(BUSINESS WIRE)--Nov. 11, 2018--
(NASDAQ: ABMD) announces the results of the FDASTEMI
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.
This press release features multimedia. View the full release here:
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.
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
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
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).
View source version on businesswire.com: https://www.businesswire.com/news/home/20181111005043/en/
Tom Langford, 978-882-8408
and Public Relations
Goldberg Ward, 978-646-1590
Director, Investor Relations