First-Ever Presentation on Abiomed's Impella® Quality (IQ) Assurance Program and Importance of Treatment Protocols to Improve Patient Survival and Heart Recovery at the 2017 American College of Car...
(Thomson Reuters ONE) -
- 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) 66(th) 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 AMICS(5), 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 AMICS(1,2). 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."
Survival Survival Standardized
Impella Sites Survival Improvement Improvement Protocols for
(Absolute %) (Relative %) Heart
Recovery
IQ Database 1,010 58% 7% 14% No
n=15,529 Hospitals
Top 20% IQ 158 76% 25% 50% Yes
n=3051 Hospitals
Detroit CSI 5 Hospital 84% 33% 65% Yes
n=37 Systems
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 PCI(6) 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.
1. Wayangankar, S. et. al J Am Coll Cardiol. Int CATH-PCI Registry.
2. Prondzinsky R. et al. Jn Critical Care Medicine IABP-SHOCK I 2010 -
Clinicaltrial.gov # NCT00469248.
3. 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.
4. 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.
5. 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.
6. 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(at)abiomed.com
Ingrid Goldberg
Director, Investor Relations
978-646-1590
igoldberg(at)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
Unternehmensinformation / Kurzprofil:
Datum: 21.03.2017 - 07:01 Uhr
Sprache: Deutsch
News-ID 531338
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contact information:
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