- Real-World Data Representing 15,259
Patients
Data from Abiomed’s (NASDAQ:ABMD) Impella® Quality (IQ) Assurance
Program, which includes the IQ Database and cVAD Registry, was
presented today as late-breaking Featured Clinical Research at the
American College of Cardiology (ACC) 66th Annual Scientific Session
in Washington, D.C. These data were derived from the IQ Database
documenting the real-world treatment of approximately 50,000 U.S.
patients, with a subset of 15,259 Acute Myocardial Infarction
Cardiogenic Shock (AMICS) patients. The Impella heart pump results
indicate an association between the use of best practice protocols
and improved survival and native heart recovery, as compared to
inconsistent treatment or inexperienced hospitals.
The Abiomed IQ Assurance Program is a real-world
collection of clinical information derived from the treatment of
patients with Impella devices since 2008. Trends in the
observational IQ Database, combined with information from Abiomed’s
Institutional Review Board (IRB)-approved cVAD Registry have helped
identify best practices and protocols that are associated with
improved survival and native heart recovery in hospitals using
Impella devices.
Best practice protocols include:
- Unloading the left ventricle of the heart (Door to Unload or
DTU) with Impella before percutaneous coronary intervention
(pre-PCI) in the setting of cardiogenic shock
- Reducing the escalation of inotrope therapy
- Utilizing hemodynamic monitoring for escalation and weaning
during support
- Experienced physicians implanting Impella heart pumps
Results from the IQ Database reveal that since
the Impella line of heart pumps received Pre-Market Approval (PMA)
from the United States Food and Drug Administration (FDA) in April
2016 for use in treating AMICS5, there has been an observed 14
percent relative improvement in survival as compared to the prior
year. In 2016, there were 89,000 AMICS cases nationwide, and
approximately 5,000 or about 6 percent, were treated with Impella
heart pumps. This compares with approximately 35,600 or 40 percent
treated with the intra-aortic balloon pump (IABP), even though
randomized controlled trials show no hemodynamic augmentation or
survival benefit for IABP patients in AMICS1,2. Though First 510(k)
cleared in 1976 as a result of already being on the market, the
IABP is not FDA approved as safe and effective for the AMICS
indication.
“The FDA deemed Impella devices safe and
effective in the U.S. for cardiogenic shock less than one year ago,
which has allowed us to collaborate with hospitals to expand
education on hemodynamic science and share best practices to
achieve native heart recovery across the country. We are pleased to
see improvements of 14 percent this year and recognize the
opportunity to further impact and improve the outcomes of thousands
of patients with the lessons learned by the most advanced centers
and physicians,” said Seth Bilazarian, MD, FACC, FSCAI, Chief
Medical Officer, Abiomed.
The data presented today also included new data
from the Detroit Cardiogenic Shock Initiative (DCSI), which is an
unprecedented collaboration between five heart hospitals in
Detroit. The presentation by study principal investigator William
W. O’Neill, MD, FACC, FSCAI, Medical Director of the Center for
Structural Heart Disease at Henry Ford Hospital, Detroit,
highlighted the treatment of 37 patients utilizing these best
practices and protocols derived from Abiomed’s IQ Assurance Program
and our most experienced heart hospitals.
- Applying these systematic best practices, DCSI hospitals showed
an increase in cardiogenic shock survival rates from 51 percent
baseline to 84 percent, with 100 percent of survivors discharged
home with their native heart.
“These results validate earlier studies from the
cVAD Registry that early circulatory support is critical for
survival and heart recovery in cardiogenic shock,” said Dr.
O’Neill. “We are proud of the positive results of our unprecedented
collaboration. By sharing our best practice protocols, we remain
committed to improving shock outcomes in Detroit and around the
world.”
|
Impella Sites |
Survival |
SurvivalImprovement(Absolute %) |
SurvivalImprovement(Relative %) |
StandardizedProtocols for HeartRecovery |
IQ Database n=15,529 |
1,010 Hospitals |
58% |
7% |
14% |
No |
Top 20% IQ n=3051 |
158 Hospitals |
76% |
25% |
50% |
Yes |
Detroit CSI n=37 |
5 Hospital Systems |
84% |
33% |
65% |
Yes |
These new data support prior publications with
percutaneous heart pumps (such as Impella) supporting cardiogenic
shock patients published in JACC (National trends in the
utilization of short-term mechanical circulatory support)3 and the
Journal of Interventional Cardiology (Use of Impella 2.5 in Acute
Myocardial Infarction complicated by Cardiogenic Shock)4
representing nearly 12,000 Medicare/insurance patients and 154 cVAD
Registry patients respectively.
The mission of the IQ Assurance Program is to
improve real-world outcomes in Protected PCI and cardiogenic shock
patients through training, education and utilization of clinical
guidelines, protocols and best practices derived from observational
quality assurance data (IQ), IRB approved registry data (cVAD) and
IDE approved FDA studies. The points reflected specifically in the
IQ Database, as compared to the IQ Program, which includes the cVAD
Registry and FDA studies, are not statistically-powered or
pre-specified, and no statistical conclusions can be drawn from the
observational database.
"Abiomed has invested to create the largest
high-risk PCI6 and cardiogenic shock database of real-world
evidence," said Michael R. Minogue, Abiomed President, Chairman and
Chief Executive Officer. "We believe that by sharing our
data-driven insights and clinical expertise, along with our 24x7
onsite and on-call support, we can help hospitals improve outcomes
and reduce costs for the sickest patients in the system."
ABOUT IMPELLA HEART PUMPS
The Impella 2.5®, Impella CP® and Impella 5.0®
are FDA-approved heart pumps used to treat heart attack 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 2.5 and Impella CP devices are also 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. Abiomed's right-side heart pump, the Impella RP® device,
is approved to treat certain patients experiencing right heart
failure. 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, and Recovering
Hearts. Saving Lives. are registered trademarks of ABIOMED, Inc. in
the U.S. and in certain foreign countries.
ABOUT
ABIOMED 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 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.
- Wayangankar, S. et. al J Am Coll Cardiol. Int CATH-PCI
Registry.
- Prondzinsky R. et al. Jn Critical Care Medicine IABP-SHOCK I
2010 – Clinicaltrial.gov # NCT00469248.
- Stretch, R. National trends in the utilization of short-term
mechanical circulatory support: incidence, outcomes, and cost
analysis. J Am Coll Cardiol. 2014 Oct 7;64(14):1407-15. doi:
10.1016/j.jacc.2014.07.958.
- O’Neill, W. The current use of Impella 2.5 in Acute Myocardial
Infarction complicated by Cardiogenic Shock: Results from the
USpella Registry. J Interv Cardiol. 2014 Feb; 27(1): 1–11.
doi: 10.1111/joic.12080.
- The data submitted to the FDA in support of the PMA included an
analysis of 415 patients from the RECOVER 1 study and the U.S.
Impella registry (cVAD Registry™), as well as an Impella literature
review including 692 patients treated with Impella from 17 clinical
studies. A safety analysis reviewed over 24,000 Impella treated
patients using the FDA medical device reporting ("MDR") database,
which draws from seven years of U.S. experience with Impella. In
addition, the Company also provided a benchmark analysis of Impella
patients in the real-world Impella cVAD registry vs. these same
patient groups in the Abiomed AB5000/BVS 5000 Registry. The Abiomed
BVS 5000 product was the first ventricular assist device (VAD) ever
approved by the FDA in 1991 based on 83 patient PMA study. In 2003,
the AB5000 Ventricle received FDA approval and this also included a
PMA study with 60 patients.For this approval, the data source for
this benchmark analysis was a registry ("AB/BVS Registry") that
contained 2,152 patients that received the AB5000 and BVS 5000
devices, which were originally approved for heart recovery. The
analysis examined by the FDA used 204 patients that received the
AB5000 device for the same indications. This analysis demonstrated
significantly better outcomes with Impella in these patients. The
Company believes this is the most comprehensive review ever
submitted to the FDA for circulatory support in the cardiogenic
shock population.
- The Impella 2.5 heart pump received FDA PMA approval to treat
certain elective and urgent high risk PCI patients in March of
2015. The Impella CP heart pump was subsequently approved to treat
that patient population in December 2016. The data underpinning the
FDA’s approval of the Impella 2.5 device included U.S. clinical
trial data from the PROTECT I FDA safety study and the PROTECT II
randomized clinical trial.Additionally, the PMA submission for the
Impella 2.5 device included an analysis of 637 high risk patients,
from 49 separate centers, enrolled in the cVAD Registry (formerly
known as the U.S. Impella registry), which now contains nearly
3,000 patient records and includes Institutional Review Board (IRB)
approval, complete data monitoring and Clinical Events Committee
adjudication. The Impella 2.5 PMA submission also included clinical
and scientific supporting evidence from more than 215 publications,
totaling 1,638 Impella 2.5 patients and incorporated a medical
device reporting (MDR) analysis from 13,981 Impella 2.5 patients.
In additional to this comprehensive data set, the FDA’s PMA
approval for the Impella CP device included its consideration of 72
high risk Impella CP patients from the CVAD Registry, as well as an
additional 637 Impella 2.5 device patients.
**For further information please contact:
Adrienne Smith
Senior Director, Public Relations and Corporate Communications
978-646-1553
adsmith@abiomed.com
Ingrid Goldberg
Director, Investor Relations
978-646-1590
igoldberg@abiomed.com
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