DANVERS, Mass.--(BUSINESS WIRE)--Apr. 4, 2019--
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.
This press release features multimedia. View the full release here:
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
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).
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.
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).
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).
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.
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).
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
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
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
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.
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
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190404005387/en/
Source: Abiomed, Inc.
Director, Communications and Public Relations
Ingrid Goldberg Ward
Director, Investor Relations