Impella RP Post-Approval Study Data Presented at ACC 2019

Data demonstrates survival benefit with the Impella RP Recover Right
protocol

NEW ORLEANS, La.–(BUSINESS WIRE)–lt;a href="https://twitter.com/hashtag/heartrecovery?src=hash" target="_blank"gt;#heartrecoverylt;/agt;–Abiomed
(NASDAQ:ABMD), a leading provider of breakthrough heart support
technologies and the maker of the Impella
RP heart pump, announces that survival data from the 18 month
post-approval study of 42 Impella RP patients was presented at the American
College of Cardiology’s (ACC) 68th Annual Scientific Session in New
Orleans. The Impella RP is the only percutaneous technology with FDA PMA
approval for right heart support designated safe and effective. The
table below summarizes the new post-approval study data and compares it
to the FDA study results submitted for Impella RP’s PMA approval.

The post-approval study data was reviewed and submitted to the FDA by
Abiomed on Wednesday, March 13, 2019. The FDA has confirmed the
classification of patients into two categories: Recover Right protocol
and salvage support. The Recover Right protocol includes patients who
met the inclusion and exclusion criteria of the Recover Right FDA PMA
clinical trial for Impella RP. The FDA also recognizes salvage patients
as those outside the Recover Right protocol (>48 hours in cardiogenic
shock from right side failure.)

The baseline characteristics of the two populations were different with
higher mortality in the salvage group. Salvage patients are some of the
sickest patients in the hospital and many have suffered out-of-hospital
cardiac arrest or may have been transferred to multiple hospitals before
receiving Impella RP. The FDA and Abiomed believe that physicians should
have the ability to attempt lifesaving recovery measures on these
patients based on their best judgement. Tim
Deits, a 16-year-old Impella RP patient from Huntington Beach,
Calif., is an example of an extremely sick patient who experienced an
unwitnessed out-of-hospital cardiac arrest event, received CPR, and
survived with recovery of his native heart.

The Impella RP post-approval study data compares to a survival rate of
73% in the Impella RP PMA Study, 42% for surgically implanted CentriMag
RVAS HDE study protocol, and 29% – 42% self-reported survival to
transfer or discharge for adult cardiac ECMO patients¹. To
note, the Recover Right protocol matches the CentriMag surgical protocol
defined by the FDA as right-side failure. The Impella RP is the only
device submitting post-approval study data on real-world patient
outcomes, including salvage utilization. This patient population will
continue to be studied in the ongoing cVAD Study.

“When a patient is in right heart failure, Impella RP allows the heart
to rest and recovers the heart’s ability to pump blood,” said David
Wohns, MD, Chief of Cardiology at Spectrum Health. “The Impella RP is an
effective treatment for patients who receive a timely implant and meet
the Recover Right inclusion and exclusion criteria.”

“The post-approval study data is analogous to our own independent data
from multiple hospitals in the Cardiogenic Shock Working Group, which
found an approximate 80% survival rate when the Impella RP was used in
cardiogenic shock patients who met inclusion criteria from the Recover
Right Study,” said Navin Kapur, MD, Executive Director of the
CardioVascular Center for Research and Innovation at Tufts Medical
Center. “Data like these highlight how the use of algorithms to
recognize right sided failure and protocols for early hemodynamic
support can help improve outcomes for cardiogenic shock patients.”

Abiomed encourages clinicians to review proper inclusion and exclusion
criteria for Impella RP and to follow guidelines, which recommend
implantation of Impella RP within 48 hours of cardiogenic shock onset
caused by right side failure. Abiomed also encourages the use of best
practices such as the National
Cardiogenic Shock Initiative and the Shock
Care Pathway Algorithms. Abiomed is committed to improving outcomes
by leading in data collection within our commercial IQ Database and cVAD
post-approval studies in order to identify and validate best practices.

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. The Impella RP^®
is FDA approved to treat right heart failure or decompensation following
left ventricular assist device implantation, myocardial infarction,
heart transplant, or open-heart surgery. 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 United
States and in certain foreign countries.

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.

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 2019 ELSO International Summary

Contacts

For further information please contact:

Tom Langford
Director, Communications and Public Relations
978-882-8408
[email protected]

Ingrid Goldberg Ward
Director, Investor Relations
978-646-1590
[email protected]