FDA Approves Impella 5.0 & Impella LD Extended Duration of Use to 14 Days for Cardiogenic Shock Derived from AMI or Cardiomyo...
May 13 2019 - 12:00PM
Business Wire
Abiomed (NASDAQ:ABMD) announces the U.S. FDA has approved
the expansion of the Impella 5.0 and Impella LD PMA labeling for
the treatment of cardiogenic shock. The expansion extends the
duration of support for each pump from 6 days to 14 days. The
Impella 5.0 and the Impella LD are forward flow heart pumps that
deliver up to 5 L/min, stabilizing a patient’s hemodynamics,
unloading the left ventricle, and perfusing the end organs,
allowing for the potential of native heart recovery or return to
heart function baseline. The Impella 5.0 is implanted through the
femoral or axillary artery and the Impella LD is implanted directly
into the aorta. Both allow patients to walk around the unit while
on support.
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Erin Hanussak, then 33 years old,
suffered from myocarditis and went into cardiogenic shock. She
benefited from Impella CP and Impella 5.0 support. (Photo: Abiomed,
Inc.)
Impella heart pumps have FDA PMA approval to treat heart attack
patients in cardiogenic shock, and for shock associated with
peripartum cardiomyopathy or myocarditis, and have the unique
ability to enable the heart to rest and recover, allowing patients
to return home with their own heart. The expanded indication allows
for the opportunity to provide longer duration of support for
critically ill patients and a longer period of assessment of heart
recovery.
One patient who benefited from Impella 5.0 support is Erin
Hanussak, then 33 years old, who suffered from myocarditis and went
into cardiogenic shock. Her ejection fraction was 15%. Under the
care of Jacob Abraham, MD, a Heart Failure Cardiologist at
Providence St. Vincent Medical Center and Medical Director of its
Center for Advanced Heart Disease, physicians implanted the Impella
CP heart pump. Although Erin’s condition improved, the team
determined that her heart needed additional support. Surgeons
inserted the Impella 5.0 into her axillary artery, which allowed
Erin to begin physical therapy and walk the hospital corridors with
hospital staff. Her kidneys began to improve and after 12 days, the
Impella 5.0 was explanted. Erin returned home to her family with
her native heart and is back to her busy life as a mom.
“Early recognition, escalation and a heart team approach are
crucial for patients in cardiogenic shock,” said Dr. Abraham. “The
Impella 5.0 and Impella LD’s ability to provide greater hemodynamic
support and unload the left ventricle make them ideal tools for
patients like Erin who need longer duration support and will
benefit from ambulation.”
The FDA’s original PMA approval indicating Impella as safe and
effective for the treatment of cardiogenic shock was granted in
2016. This approval was based on an analysis of 415 patients from
the FDA study RECOVER 1 and the U.S. Impella registry, and an
Impella literature review of 692 patients in 17 clinical studies.
Additionally, more than 24,000 Impella patients supported by
Impella devices were reviewed in a safety analysis.
The Impella heart pump platform 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.
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.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190513005623/en/
Tom LangfordDirector, Communications and Public
Relations978-882-8408tlangford@abiomed.comIngrid Goldberg
WardDirector, Investor
Relations978-646-1590igoldberg@abiomed.com
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