Data presented today from the National Cardiogenic Shock
Initiative Study (NCSI) on 250 consecutive AMI cardiogenic shock
(AMICS) patients from 49 sites demonstrates 72% survival at
discharge with 98% native heart recovery. The patients were treated
with the NCSI protocol, which includes placing Abiomed’s (NASDAQ:
ABMD) Impella heart pump before revascularization via percutaneous
coronary intervention (PCI). 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 by William O’Neill, MD,
medical director of the Center for Structural Heart Disease at
Henry Ford Hospital, during the 31st Transcatheter Cardiovascular
Therapeutics (TCT) conference in San Francisco.
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Prior to the NCSI, cardiogenic shock survival rates had
stagnated for the last 20 years at around 50%. The investigators of
the physician-led NCSI are implementing protocols to increase
survival and achieve native heart recovery.
The NCSI protocols are derived from best practices that include
identifying cardiogenic shock early, minimizing the use of
inotropes and placing Impella CP prior to revascularization (PCI).
The evidence supporting the best practice of placing Impella
pre-PCI comes from thousands of patients in the Impella IQ
Database, cVAD Study, Hannover Registry and Detroit Cardiogenic
Shock Initiative.
Investigators now plan to institute new escalation protocols
that will be applied in the cath lab immediately after
Impella-supported PCI in order to further increase patient survival
and native heart recovery. The escalation protocols are based on
learnings from the Cardiogenic Shock Working Group, the cVAD Study
and initial NCSI data.
Specifically, the escalation protocols are:
- After Impella-supported PCI, if the patient is on one inotrope
and has a cardiac power output (CPO) of less than 0.8 watts,
escalate to Impella 5.0 within 6 hours
- After Impella-supported PCI, if the patient is in right
ventricular (RV) dysfunction, quickly escalate to Impella RP or
provide oxygenation
“By quickly identifying and escalating patients who need
additional support, I believe we can increase cardiogenic shock
survival rates to 75%,” said William O’Neill, MD, medical director
of the Center for Structural Heart Disease at Henry Ford Hospital.
“Physicians around the country have already demonstrated that use
of a standardized protocol that includes early placement of the
Impella heart pump can dramatically increase survival and native
heart recovery. These new escalation protocols can help even more
patients return home to their families.”
Since receiving FDA 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.
“Cardiogenic shock is a state of critical end organ
hypoperfusion and unloading with Impella is an FDA approved therapy
for patients,” said Seth Bilazarian, MD, the chief medical officer
of Abiomed. “Protocols derived from the real-world evidence
collected in multiple registries and studies demonstrate unloading
with Impella prior to PCI is a crucial component to improvement in
survival.”
Impella has the highest level of FDA approval as a therapy for
cardiogenic shock to reduce ventricular work and provide the
circulatory support necessary to allow heart recovery and early
assessment of residual myocardial function.
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®, Impella LD®, and Impella 5.5™ with
Smart Assist® 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. Impella is the
most studied mechanical circulatory support device in the history
of the FDA with real world clinical data on more than 100,000
patients and more than 550 peer-reviewed publications.
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™
with Smart Assist® 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190927005103/en/
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
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