Abiomed (NASDAQ: ABMD) announces that, on April 26, the FDA
approved initiation of the ST-Elevation Myocardial Infarction
Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial.
The prospective, multi-center, two-arm trial plans to enroll 668
patients undergoing treatment for a STEMI heart attack. Half the
patients will be randomized to receive delayed reperfusion after 30
minutes of left ventricular unloading with the Impella CP. The
other half will receive immediate reperfusion, the current standard
of care.
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the full release here:
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The STEMI DTU safety and feasibility
trial, when compared to the standard of care (reperfusion only) arm
of the CRISP AMI trial demonstrates the potential to reduce infarct
size in STEMI. (Graphic: Business Wire)
The trial will test the hypothesis that unloading the left
ventricle for 30 minutes prior to reperfusion will reduce
myocardial damage from a heart attack and lead to a reduction in
future heart failure related events. Myocardial damage can lead to
an infarct, and every 5% increase in infarct size is associated
with a 20% increase in relative hazard for all-cause mortality or
hospitalization for heart failure within one year after a primary
PCI1. Coronary artery disease is the number one cause of death in
the United States. 47% of women and 36% of men over the age of 45
will die within 5 years of their first heart attack2.
“The STEMI DTU Pivotal Trial has the potential to improve the
standard of care, slow the growing epidemic of heart failure and
improve outcomes for millions of heart attack patients. This trial
is the first of its kind to focus on ventricular unloading as part
of a therapeutic approach for heart attacks without cardiogenic
shock and could lead to a paradigm shift in the way heart attack
patients are treated worldwide,” said Navin Kapur, MD, the study’s
co-principal investigator and the executive director of the
CardioVascular Center for Research and Innovation (CVCRI) at Tufts
Medical Center.
Study Summary
Planned Enrollment:
- 668 subjects, enrolled at up to 60
sites
- Additionally, the protocol requires
each site to “roll-in” two patients (one in each arm) to test the
study protocol before beginning enrollment. The trial allows for an
adaptive design, which permits adjustments to the study sample size
after an interim analysis.
Expected Timeline:
- Enrollment begins in October 2019 and
is expected to end in 3-4 years, 2022-2023
- 6 months after enrollment completion:
FDA submission for indication approval, based on primary endpoint
and safety data analysis
Endpoints:
- Primary Endpoint - Infarct size as a
percent of left ventricular mass, measured at 3-5 days using
cardiac MRI
- Key Secondary Effectiveness Endpoint -
A composite of the primary endpoint and the following:
- Cardiogenic shock after 24 hours post
enrollment out to 30 days
- Cardiovascular mortality at 24
months
- Heart failure requiring hospitalization
at 24 months
- Implantable cardioverter-defibrillator
(ICD) and cardiac resynchronization therapy (CRT) placement at 24
months
- The trial is powered for multiple other
secondary endpoints and has numerous exploratory endpoints, such as
infarct size to area at risk
Projected Budget:
- $25 million to complete enrollment with
an additional two-year follow up to clinical secondary
endpoints
Reimbursement:
- Reimbursement for the Impella device is
anticipated for patients in the study through CMS category B, as it
was during the STEMI DTU safety and feasibility trial
A detailed protocol synopsis is available at this link.
The pivotal trial will build on the promising results of the
successful STEMI DTU safety and feasibility trial, which met its
goal by demonstrating it is safe and feasible to conduct a study of
30 minutes of unloading with delayed reperfusion. The accompanying
chart compares the safety and feasibility trial results to the
CRISP AMI trial’s standard of care arm (reperfusion only) and
demonstrates how 30 minutes of unloading prior to reperfusion has
the potential to reduce infarct size in STEMI.
“A successful study will transform the treatment of heart
attacks and reduce heart failure for hundreds of thousands of
patients each year. As a result, it is important to execute with
the highest scientific rigor to ensure a successful study concludes
with a Class I recommendation to reach 200,000 U.S. heart attack
patients and more than 4 million patients outside the U.S.,” said
Michael R. Minogue, Chairman, President and CEO of Abiomed.
The pivotal trial will be overseen by a steering committee of
five expert cardiologists and clinical trialists. They are: Dr.
Kapur, William O’Neill, MD, medical director of
the Center for Structural Heart Disease at Henry
Ford Hospital, Jeffrey Moses, MD, professor of medicine at
Columbia University Medical Center and director of interventional
cardiovascular therapeutics at Columbia University Medical Center,
Gregg Stone, MD, professor of medicine at Columbia
University College of Physicians and Surgeons and director of
cardiovascular research and education at the Center for
Interventional Vascular Therapy at New York-Presbyterian
Hospital/Columbia University Medical Center, and James
Udelson, MD, chief of the division of cardiology at Tufts
Medical Center.
The trial is sponsored by Abiomed. 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.
Impella is the most studied mechanical circulatory support
device in the history of the FDA and has exclusive PMA approvals
for high-risk PCI, as a therapy to allow for native heart recovery
after cardiogenic shock derived from AMI or cardiomyopathy, and
right ventricular heart failure.
The Abiomed logo, Abiomed, Impella, Impella 2.5, Impella 5.0,
Impella LD, Impella CP, Impella RP, Impella Connect, 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 Stone, et al., Relationship Between Infarct Size and Outcomes
Following Primary PCI, JACC, 2016
2 Heart Disease and Stroke Statistics 2019 Update: A Report from
the American Heart Association Statistics Committee and Stroke
Statistics Subcommittee." (Circulation. 2019;139(10):56–528).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190502005270/en/
Tom LangfordDirector, Communications and Public
Relations978-882-8408tlangford@abiomed.com
Ingrid Goldberg WardDirector, Investor
Relations978-646-1590igoldberg@abiomed.com
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