DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (NASDAQ:ABMD) announces today that the Impella
CP with SmartAssist, which is designed to improve patient outcomes
with advanced algorithms and simplified patient management, will be
commercially available beginning at the 2019 Society for Cardiovascular
Angiography & Interventions (SCAI) Scientific Sessions through a
controlled launch process at select sites. The majority of Impella CP
heart pumps in the U.S. will be transitioned to SmartAssist over the
next fiscal year.
U.S. FDA approval for Impella CP with SmartAssist in March 2018.
During a limited market release over the past year, more than 1,000
patients at 70 sites have been treated with the SmartAssist platform.
These advances in Impella forward-flow heart pump technologies and
software are designed to improve ease-of-use and patient management to
optimize both survival and heart recovery:
Weaning Algorithms to Optimize Survival and Native Heart Recovery:
Real-time displays of critical hemodynamic metrics including left
ventricular end-diastolic pressure (LVEDP), mean arterial pressure
(MAP), and cardiac power output (CPO). Impella CP with SmartAssist is
the only mechanical circulatory support device that calculates and
displays LVEDP, MAP and CPO.
Easier Management and Repositioning: SmartAssist sensor allows
for precise positioning in the aorta and left ventricle and
repositioning in the ICU without the need for catheterization lab or
Greater Hemodynamic Support: Allows for sustained peak flows of
up to 4.3L/minute (>85% of a normal cardiac cycle).
- Faster, Simplified Impella Console Set Up: Less than 90 seconds.
“Access to real-time clinical data has allowed our team to identify best
practices for patient management and weaning,” said Hiram Bezerra,
interventional cardiologist, University Hospitals, Cleveland, and a
participant in the limited market release. “Metrics such as LVEDP, MAP
and CPO and the ability to monitor trends on the Impella console allow
physicians to utilize this hemodynamic information to optimize heart
recovery with objective and quantifiable data to enable clear
communication within the shock team.”
The SmartAssist platform is complemented by Abiomed’s industry-leading
on-site and on-call support, including the Clinical Support Center,
which provides 24×7 expert evaluation of Impella data and collaborative
patient care to help improve outcomes.
“The SmartAssist platform represents the next generation of heart
recovery products,” said Michael R. Minogue, Chairman, President and CEO
of Abiomed. “SmartAssist represents Abiomed’s continued commitment to
provide world-class innovation and unparalleled service to help
physicians, nurses and ICU staff improve patient outcomes for both
survival and native heart recovery.”
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® and Impella LD® 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.
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.
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.
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.
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