Data demonstrates survival benefit with the
Impella RP Recover Right protocol
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.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20190318005252/en/
The Impella RP FDA post-market study data
shows 64% survival rate for patients who meet the Recover Right
criteria. (Photo: Abiomed, Inc.)
Impella RP Post-Approval Study (PAS)
Results with and without Recover Right Protocol
Post-Approval Study (PAS) – (N=42)
Survival Rates
Recover Right Protocol Population
(N=14)
64% (9/14)
Salvage Patient Population (N=28)
11% (3/28)
American College of Cardiology Scientific
Session, 2019
Impella RP Pre-market Approval (PMA)
Study Results with Recover Right Protocol
Survival Rates
PMA Subjects (RR + CAP + HDE PAS) – full
cohort (N=60)
73% (44/60)
Cohort A – LVAD Patients (N=31)
77% (24/31)
Cohort B – Shock Patients (N=29)
69% (20/29)
Journal of Heart and Lung Transplant,
December 2018 (37)
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
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190318005252/en/
For further information please contact:
Tom LangfordDirector, Communications and Public
Relations978-882-8408tlangford@abiomed.com
Ingrid Goldberg WardDirector, Investor
Relations978-646-1590igoldberg@abiomed.com
ABIOMED (NASDAQ:ABMD)
Historical Stock Chart
From Mar 2024 to Apr 2024
ABIOMED (NASDAQ:ABMD)
Historical Stock Chart
From Apr 2023 to Apr 2024