National Cardiogenic Shock Initiative (NCSI) with Impella Best Practices Demonstrates 72% Survival with 98% Native Heart Recovery

Improves upon AMI cardiogenic shock historical survival of 50%

LAS VEGAS–(BUSINESS WIRE)–lt;a href="https://twitter.com/hashtag/heartrecovery?src=hash" target="_blank"gt;#heartrecoverylt;/agt;–Abiomed (NASDAQ:ABMD) announces that new data from the National
Cardiogenic Shock Initiative Study (NCSI) on 171 consecutive AMI
cardiogenic shock (AMICS) patients from 35 sites demonstrates 72%
survival with 98% native heart recovery at discharge. The patients were
treated with the NCSI protocol, which includes placing the Impella heart
pump before revascularization. The study demonstrates the protocol-based
approach to increasing survival rates in cardiogenic shock is
reproducible in academic and community hospitals across the United
States. Results were presented at the 2019
Society for Cardiovascular Angiography & Interventions (SCAI) Scientific
Sessions and simultaneously published in Catheterization
and Cardiovascular Interventions (CCI).

The investigators of the physician-led NCSI represent the largest
working group studying the effects of mechanical circulatory support in
AMICS patients. Their goals are to increase cardiogenic shock survival,
which has stagnated for the last 20 years at around 50% and provide
unloading therapy to achieve native heart recovery¹. The NCSI
protocol includes best practices of placing Impella pre-PCI, identifying
shock early and minimizing the use of inotropes. These best practices
were identified retrospectively through Abiomed’s Impella Quality (IQ)
Database and the U.S. Impella Registry, now called the cVAD Study, and
were tested and validated prospectively in the original
Detroit CSI study, which demonstrated improved survival and native
heart recovery.

The NCSI used patient selection criteria that mimicked prior cardiogenic
shock studies^2,3. Patients included in the study were treated
between July 2016 and February 2019.

Patient Characteristics
Demographics			All (n=171)
Average age			63 years
Gender – male			77%
AMI cardiogenic shock present on admission			68%
On inotropes or vasopressors prior to or during index procedure			83%
Witnessed out-of-hospital cardiac arrest			20%
In-hospital cardiac arrest			29%
CPR at the time of Impella insertion			10%

“By adopting the NCSI protocol, physicians around the country have
standardized the treatment of cardiogenic shock and are improving
patient outcomes by using best practices which include early placement
of the Impella heart pump,” said William O’Neill, MD, medical director
of the Center for Structural Heart Disease at Henry Ford Hospital.
“Similar to door-to-balloon time, the adoption of these best practices
is an evolution in clinical practice that will benefit our sickest
patients. Tracking, collecting and applying real-world evidence will
allow physicians to continue to increase survival and heart recovery for
these patients.”

“This new clinical data validates, as prior publications have
demonstrated, the importance of best practice protocols to improve
survival and native heart recovery for patients with cardiogenic shock,”
said Michael R. Minogue, Chairman, President and Chief Executive Officer
of Abiomed. “Abiomed is committed to investing in innovation, clinical
research with prior and future FDA studies, and analyzing real-world
evidence through our Impella Quality (IQ) Database and cVAD Study. We
will continue to partner with physicians and hospital teams to create
the field of heart recovery.”

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.
• Journal
  of the American College of Cardiology, 2019: 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).

1. Impella has exclusive
FDA approval as a therapy for cardiogenic shock to allow for native
heart recovery.
2. Intra-aortic Balloon Support for Myocardial
Infarction with Cardiogenic Shock; Thiele, H, et al., New England
Journal of Medicine. 2012 Oct 4; DOI: 10.1056/NEJMoa1208410
3. PCI
Strategies in Patients with Acute Myocardial Infarction and Cardiogenic
Shock: Results of the Culprit-Shock Trial; Thiele, H. et al., New
England Journal of Medicine. 2017 Dec 21; DOI: 10.1056/NEJMoa1710261

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.

Contacts

Tom Langford
Director, Communications and Public Relations
978-882-8408
tlangford@abiomed.com

Ingrid Goldberg Ward
Director, Investor Relations
978-646-1590
igoldberg@abiomed.com