Abiomed’s (NASDAQ: ABMD) newest heart pump, the Impella 5.5 with
SmartAssist, has received U.S. Food and Drug Administration (FDA)
pre-market approval (PMA) for safety and efficacy in the therapy of
cardiogenic shock for up to 14 days.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20190925005454/en/
Impella 5.5 with SmartAssist delivers
peak flows of greater than 6 liters per minute. A motor housing
that is thinner and 45% shorter than the Impella 5.0 improves ease
of pump insertion through the vasculature. (Photo: Business
Wire)
Impella 5.5 with SmartAssist is:
- Minimally invasive, eliminating the need for a
sternotomy or coring of the left ventricle
- Designed for heart surgeons, implanted via the axillary
artery or the anterior aorta
- Forward flow, to provide the patient with coronary flow
and renal perfusion
- Fully unloading, to reduce the heart’s oxygen demand and
work
- Equipped with SmartAssist, designed to provide weaning
algorithms to optimize survival and native heart recovery
“A minimally invasive, forward flow, fully unloading heart pump
that is designed for surgery is game changing,” said Mark Anderson,
M.D., chief of the Division of Cardiac Surgery and cardiothoracic
surgeon at the Heart and Vascular Hospital at Hackensack University
Medical Center and Hackensack Meridian Health. “This gives cardiac
surgeons a new and potentially better option that can provide the
benefits of heart recovery to some of our sickest patients.”
“The Impella 5.5 is designed to give severely ill patients the
best chance for recovery of the heart," said Hermann
Reichenspurner, MD, PhD, professor and chief, Department of
Cardiovascular Surgery, University Heart Center Hamburg. "A forward
flow, minimally invasive heart pump that unloads the left ventricle
and perfuses the end organs adequately is an ideal tool to help
stabilize a patient after cardiac decompensation and give the heart
time to rest and recover."
The FDA indication for use of Impella 5.5 with SmartAssist is as
follows:
The Impella 5.5 with SmartAssist System is a
temporary ventricular support device intended for short term (14
days) use and indicated for the treatment of ongoing cardiogenic
shock that occurs immediately (< 48 hours) following acute
myocardial infarction or open heart surgery or in the setting of
cardiomyopathy, including peripartum cardiomyopathy, or myocarditis
as a result of isolated left ventricular failure that is not
responsive to optimal medical management and conventional treatment
measures (including volume loading and use of pressors and
inotropes, with or without IABP). The intent of Impella System
Therapy is to reduce ventricular work and to provide the
circulatory support necessary to allow heart recovery and early
assessment of residual myocardial function.
Impella 5.5 with SmartAssist delivers peak flows of greater than
6 liters per minute. A motor housing that is thinner and 45%
shorter than the Impella 5.0 improves ease of pump insertion
through the vasculature.
The inclusion of SmartAssist enables intelligent decision making
with weaning algorithms designed to increase survival with heart
recovery. SmartAssist also integrates data informatics including
left ventricular pressure (LVP), end-diastolic pressure (EDP) and
cardiac power output (CPO). The SmartAssist fiberoptic pressure
sensor allows for precise pump positioning, management and
repositioning in the ICU. Impella Connect enables clinicians to
view the Impella control screen through a secure, HIPAA compliant
website to track and review cases at any time from any
internet-connected device.
The Impella 5.5 with SmartAssist will be introduced in the
United States through a controlled rollout at hospitals with
established heart recovery protocols. Impella 5.5 with SmartAssist
received CE marking approval in Europe in April 2018 and was
introduced in Germany through a similar controlled rollout.
The supplement approval for the Impella 5.5 with SmartAssist
stems from the FDA’s Impella PMA approvals indicating Impella
devices as safe and effective for the treatment of cardiogenic
shock. The approvals were based on analyses of Impella clinical
results in 508 patients, which includes the FDA study RECOVER I,
and the U.S. Impella registry, and of Impella literature reviews of
801 patients in 33 clinical studies. Additionally, more than 49,000
patients supported by Impella technology were reviewed in a safety
analysis.
ABOUT IMPELLA HEART PUMPS
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 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™
heart pump 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190925005454/en/
Tom Langford Director, Communications and Public Relations
978-882-8408 tlangford@abiomed.com
Ingrid Goldberg Ward Director, Investor Relations 978-646-1590
igoldberg@abiomed.com
ABIOMED (NASDAQ:ABMD)
Historical Stock Chart
From Mar 2024 to Apr 2024
ABIOMED (NASDAQ:ABMD)
Historical Stock Chart
From Apr 2023 to Apr 2024