Use of early identification protocol leads to higher survival and
native heart recovery, as demonstrated in FDA studies
DANVERS, Mass.--(BUSINESS WIRE)--May 21, 2019--
In a letter sent to healthcare providers today, the U.S. FDA validates
that Abiomed’s (NASDAQ:
RP heart pump is safe and effective for treatment of right heart
failure. The letter comes after the FDA examined the results from
Abiomed’s 18-month post-approval study (PAS) of 42 Impella RP patients.
The data shows a 64% survival rate and 90% heart recovery for the
subgroup of PAS patients who met the enrollment criteria of Impella RP’s
premarket clinical studies. That survival rate is, as the FDA writes in
its letter, “similar to the premarket clinical study survival rate,”
which was 73%. A control group humanitarian device exemption (HDE) study
of a non-Impella surgical device1 using the same protocol
showed a survival rate of 43%.
FDA Data Source
Post-approval study (n=14)
Premarket clinical studies (RR + CAP + HDE PAS) (n=60)
PMA control group data (non-Impella surgical device) (n=24)
The FDA letter emphasizes the need for early patient selection and
determines late identification and treatment of cardiogenic shock as the
root cause of differences between the survival rate in the pre-market
study and the PAS. The FDA writes, “PAS patients who would not have
qualified for the premarket clinical studies were more likely to have
been in cardiogenic shock for longer than 48 hours, experienced a
cardiac arrest, or suffered a pre-implant hypoxic or ischemic neurologic
event before getting the Impella RP system implanted.” Healthcare
providers are encouraged to use the Impella
RP checklist, which the FDA and Abiomed collaborated to develop, to
assist with proper patient selection to optimize outcomes.
The FDA has no safety concerns about the Impella RP itself and noted the
ongoing collaboration between the agency and Abiomed during this
process, including interactive labeling updates around patient selection
guidelines and best practices. The 18-month PAS report has been accepted
by the FDA and is successfully closed.
Impella RP is the most studied right-sided device and the only
percutaneous technology with FDA approval designating it as safe and
effective for right heart support. Its exclusive FDA approval is a
result of five years of research that included:
RECOVER RIGHT, an FDA-approved, prospective, multicenter, single-arm
study, which commenced after the company received FDA investigational
device exemption (IDE) approval in November 2012 and concluded in 2014.
HDE approval study, which was completed in January 2015
A Continuous Access Protocol (CAP)
- FDA post-approval study, initiated after PMA approval in September 2017
Abiomed is committed to improving patient outcomes by performing
post-market patient surveillance and FDA studies, collecting real-world
evidence and developing best practices. Abiomed tracks outcomes on
nearly 100% of its U.S. patients through its Impella Quality (IQ)
Database, helps improve patient outcomes in real-time through its
Impella Connect cloud-based platform, and prospectively conducts FDA
clinical studies through its IRB approved cVAD Study.
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.
1 Humanitarian Device Exemption (HDE) study of surgical VAD
is not powered for comparison but uses the same FDA protocol for right
ventricular failure. HDE criteria to meet is safe and probable benefit,
compared to safe and effective for PMA approval.
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