Three years ago this week, Abiomed's (NASDAQ: ABMD) Impella
heart pump received its FDA PMA approval for AMI cardiogenic shock.
At the time of Impella’s FDA PMA approval, the cardiogenic shock
survival rate to explant in the Impella Quality Assurance (IQ)
Database was 51% in the United States1. Today, Impella heart pumps,
combined with the adoption of best practices, which include the use
of Impella pre-PCI, have contributed to a significant increase in
cardiogenic shock survival and native heart recovery. New data from
the IQ Database on nearly 5,000 patients treated between April 2018
and March 2019 show an increase in survival from 51% to 67%2, a
relative increase of 34% in survival.
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Impella Quality Database: Cardiogenic
shock survival to explant 2009-2016 compared to 2018-2019.
(Graphic: Abiomed, Inc.)
Since FDA PMA approval, Abiomed has collected data on nearly
100% of U.S. Impella patients in the observational IQ Database.
This clinical data, combined with the FDA post-approval studies
embedded in Abiomed’s prospective cVAD Study, helped identify and
validate best practices for Impella use associated with improved
survival and native heart recovery. These best practices, including
use of Impella pre-PCI, reduction of inotropes, early
identification of shock, and hemodynamic monitoring with pulmonary
artery catheters, have now been validated in multiple
publications:
- Journal of Interventional Cardiology,
2014: Placement of Impella pre-PCI is associated with more complete
revascularization and improved survival to discharge in the setting
of AMI cardiogenic shock (65% with Impella placed pre-PCI vs. 41%
post-PCI, p=0.023).
- American Journal of Cardiology, 2017:
Initiation of Impella before PCI and prior to initiation of
inotropes or vasopressors is independently associated with improved
survival. Survival to discharge was 68%, 46%, 35%, 35%, and 26% for
patients requiring 0, 1, 2, 3, and ≥4 inotropes before mechanical
circulatory support, respectively (p <0.001), in an analysis of
281 AMI cardiogenic shock patients.
- Journal of Interventional Cardiology,
2017: Demonstrates a 48% survival at 30 days when Impella is
implanted pre-PCI, compared to a 13% survival when Impella is
implanted post-PCI for left main in cardiogenic shock
(p=0.004).
- American Heart Journal, 2018: Analysis
of 15,259 U.S. patients in the IQ Database demonstrated an
improvement in survival to explant from 52% to 59% when Impella was
placed pre-PCI (p=0.001).
- National Cardiogenic Shock Initiative
Study Late Breaking Clinical Science, TCT 2018: Data from the first
104 patients utilizing best practices in the National Cardiogenic
Shock Initiative (NCSI) Study found 77% survival to discharge with
99% native heart recovery.
- Circulation, 2018: Analysis reinforces
best practices of reduced use of inotropes and placement of Impella
pre-PCI leads to improved survival rates. Survival benefit of
Impella pre-PCI revealed trend vs “matched” IABP-Shock: 57.3% vs.
46.7% (p=0.18). Significant survival to discharge benefit with
Impella in patients who did not receive inotropes (56.6% vs. 29.4%
p<0.01). A subset of patients from this paper was presented at
American College of Cardiology (ACC) 2019 Scientific Sessions when
Andreas Schäfer, MD, presented an abstract that showed improved
survival to discharge when Impella is placed pre-PCI of 71% vs. 49%
post-PCI (p= 0.0021).
- Journal of the American College of
Cardiology, 2018: Rab, et al., summarizes data from IQ Database,
cVAD Study and NCSI and concluded that best practices are
associated with improved survival in AMI cardiogenic shock.
New Data Published This Week
The most recent results that further validate best practices
published online this week in the Journal of the American College
of Cardiology. After Inova Heart and Vascular Institute instituted
a best practice protocol that includes early use of percutaneous
mechanical circulatory support, AMI cardiogenic shock survival at
30 days rose from 44% to 82% (p=0.0001).
“The totality of the data on Impella use for cardiogenic shock
demonstrates that coordinated care with a multidisciplinary
team-based approach, a standardized protocol, and the best
available tools, can lead to a remarkable increase in survival,”
said William O’Neill, MD, medical director of the Center for
Structural Heart Disease at Henry Ford
Hospital in Detroit. “This gives us hope for making real
improvements to patient outcomes in this patient population that
has historically been difficult to treat.”
Cardiogenic shock patients who have benefited from treatment at
leading centers from physicians who implanted Impella include Jay
Sanchez, Stephon Betts and Ricky Payne. Survival with native heart
recovery is the best option for the patient and one of the most
cost-effective medical therapies.
“Abiomed has built the field of heart recovery by partnering
with our hospitals and physicians to use real-world data, combined
with FDA post-approval studies, to identify and validate best
practices to improve patient outcomes,” said Abiomed Chairman,
President and CEO, Michael R. Minogue. “It is inspiring that, over
the last three years, cardiogenic shock patients have returned home
to their families with their native heart.”
Impella’s FDA PMA for AMI cardiogenic shock was granted based on
the following: Analysis of 494 cardiogenic shock patients from the
U.S. Impella Registry (now called cVAD Study) and the RECOVER I FDA
Study, safety and effectiveness analysis from FDA studies for
high-risk PCI (PROTECT I & PROTECT II RCT), 709 high-risk PCI
patients from U.S. Impella Registry, Impella literature review
including 692 cardiogenic shock patients and 756 high-risk PCI
patients treated with Impella, hemodynamic science demonstrating
the benefits of unloading the left ventricle to reduce work and
oxygen demand for the left ventricle and perfuse the end organs,
the Journal of American College of Cardiology article, Hemodynamics
of Mechanical Circulatory Support, D. Burkhoff et al., (2015), and
a safety analysis of more than 25,000 Impella-treated patients
using the FDA medical device reporting database, which draws from
eight years (2008-2016) of U.S. experience with Impella 510(k)
clearance. Furthermore, the RECOVER II RCT demonstrated the
difficulty in consenting and enrolling these U.S. patients due to
ethical and logistical concerns. The intra-aortic balloon pump is
now a class III recommendation in Europe and Japan based on the
IABP-Shock II study.
Impella 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
with cardiogenic shock derived from AMI or cardiomyopathy, and
right sided 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.
1 Analysis of outcomes for 15,259 U.S. patients with acute
myocardial infarction cardiogenic shock (AMICS) supported with the
Impella device; O'Neill WW et al., Am Heart J. 2018 Apr
7;202:33-38. Data is median survival.2 Median survival of AMICS
patients treated at 763 sites supporting >4 AMICS patients with
PCI. 4,891 patients total. Data on file. Abiomed Impella Quality
(IQ) Database, AMI/CGS, Apr 1, 2018 – Mar 28, 2019. Danvers, MA:
Abiomed.
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Tom LangfordDirector, Communications and Public
Relations978-882-8408tlangford@abiomed.com
Ingrid Goldberg WardDirector, Investor
Relations978-646-1590igoldberg@abiomed.com
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