- Real-World Data Representing 15,259 Patients
WASHINGTON, March 19, 2017 (GLOBE NEWSWIRE) --
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 |
Survival
Improvement
(Absolute %) |
Survival
Improvement
(Relative %) |
Standardized
Protocols for Heart
Recovery |
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(TM)), 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
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Abiomed via Globenewswire
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