Use of early identification protocol leads to
higher survival and native heart recovery, as demonstrated in FDA
studies
In a letter sent to healthcare providers today, the U.S. FDA
validates that Abiomed’s (NASDAQ: ABMD) Impella 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
Survival Rates
Post-approval study (n=14) 64% (9/14)
Premarket clinical studies (RR + CAP + HDE PAS) (n=60)
73% (44/60) PMA control group data (non-Impella
surgical device) (n=24) 43% (10/24)
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.
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.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190521005790/en/
**For further information please contact:Tom
LangfordDirector, Communications and Public
Relations978-882-8408tlangford@abiomed.comIngrid Goldberg
WardDirector, Investor
Relations978-646-1590igoldberg@abiomed.com
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