Impella is the most studied heart pump; Subject
of comprehensive post-market surveillance, 550+ academic
publications, and a landmark randomized controlled trial
In a milestone for scientific research, Abiomed (NASDAQ: ABMD)
has now invested more than $100 million over the past five years in
clinical research on the Impella heart pump platform. Abiomed’s
commitment to clinical research is detailed on a new webpage that
launched today.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20190220005532/en/
Impella research benefits patients such
as Tim Deits, who benefited from right side and left side support
from Impella RP and Impella CP when he went into cardiogenic shock.
A short film of his story is available online at:
www.abiomed.com/patients. (Photo: Abiomed, Inc.)
Abiomed-sponsored research is augmented by two decades of
independent physician-led research initiatives and a total of more
than 550 peer-reviewed academic papers. Those studies have
confirmed the hemodynamic benefits of Impella, which directly
unloads the left ventricle and enables heart recovery. As a result,
Impella is included in eight clinical guidelines¹ and has
regulatory approvals that include European CE Mark, Japanese PMDA,
and the highest level of regulatory approval from the US FDA, the
PMA.
To date, Abiomed’s commitment to clinical research has
supported:
- One of the most complete and extensive
post-market surveillance programs in the medical device industry,
including:
- The Impella Quality Assurance (IQ)
Database, which collects, and shares with independent academic
researchers for analysis, real-world outcomes data on nearly 100%
of Impella patients from more than 1,300 U.S. centers. Data from
the IQ Database helps continuously improve outcomes by, for
example, demonstrating the benefits of placing Impella prior to
revascularization in cardiogenic shock, as detailed in an Impella
Update issued to physicians today.
- The FDA-audited cVAD Study, a
prospective study with one year follow up. The cVAD Study
contributed to the development of the physician-led National
Cardiogenic Shock Initiative which demonstrates that when best
practices are followed, including the placement of Impella pre-PCI,
survival in cardiogenic shock can improve from ~50% to 77%.
- Real-time monitoring of patients
on Impella support through industry-leading 24x7 clinical support
services. These include 24-hour on-call, on-site support and the
cloud-based Impella Connect system, which lets clinicians and
experts from Abiomed’s Clinical Support Center remotely monitor
patients in real-time to help improve outcomes.
- Ten attempted or completed randomized
controlled trials of Impella (two completed, seven attempted and
one ongoing). This includes Abiomed’s support of the ongoing
Dan-Ger Shock randomized controlled trial for cardiogenic shock,
which compares Impella CP use to other types of circulatory
support.
- Six FDA studies, with five post-market
approval studies underway. These studies have demonstrated best
practices for improving patient outcomes, and established Impella
as the most cost-effective FDA-approved therapy for native heart
recovery by reducing length of stay, repeat procedures, and total
cost of patient care.
- Partnerships with leading academic
institutions to explore new elements of cardiac physiology such as
the delivery of gene therapy vectors to failing hearts, algorithms
to detect and predict patient-specific hemodynamics and how
unloading the ventricle prior to reperfusion may trigger
cardioprotective signaling.
Additionally, Abiomed plans to continue to actively support
clinical research, including two randomized controlled trials, in
2019. Planned funding includes:
- STEMI-DTU pivotal randomized controlled
trial, which will compare unloading the left ventricle with Impella
to the current standard of care.
- The ongoing Dan-Ger Shock randomized
control trial for cardiogenic shock.
- Ongoing data collection, monitoring and
analysis for the IQ Database, cVAD Study and five FDA post-market
studies.
“A commitment to clinical research is ingrained in Abiomed’s
culture because of our commitment to providing health care
providers and patients with the highest quality devices, most
cost-effective solutions and best practices for improving
outcomes,” said Seth Bilazarian, MD, Abiomed’s chief medical
officer. “Our patients are the motivation for all we do, and the
goal of our industry-leading clinical research program is to help
more patients recover their native hearts and go home to their
families.”
Impella is the only FDA approved, safe and effective device for
high-risk PCI, cardiogenic shock, and right-side support. Unlike
the majority of FDA cleared medical devices, including the
intra-aortic balloon pump and ECMO, Impella’s indications are
backed by a randomized controlled trial, Protect II, demonstrating
safety and efficacy.
More than 100,000 patients have been treated with Impella in the
U.S., Germany and Japan, including Tim Deits, a teenager who went
into cardiogenic shock after collapsing at his home in Huntington
Beach, California. He was rushed to the hospital and treated with
an Impella CP and an Impella RP, which allowed his heart to rest
and recover.
“I am thankful to everyone who helped to research the
effectiveness of the Impella heart pump. Without your hard work
over many years, my son, Tim, would not likely be alive today,”
said Tim’s father, Ted Deits. “Tim was initially given only a 10%
chance for survival. Fortunately, the Impella RP heart pump arrived
at our local hospital just weeks before Tim’s heart event, and I
feel incredibly fortunate Impella was available to help save
Tim.”
¹ Clinical society guidelines for Impella therapy:
- Cardiogenic Shock:
- 2015 SCAI/ACC/HFSA/STS Consensus
Document on Hemodynamic Support (JACC)
- 2013 International Society for Heart
and Lung Transplantation Guidelines for Mechanical Circulatory
Support (J Heart Lung Transplant)
- 2013 ACCF/AHA Guideline for the
Management of Heart Failure (JACC)
- 2013 ACCF/AHA Guideline for the
Management of ST-Elevation Myocardial Infarction (Circulation)
- 2012 Use of Mechanical Circulatory
Support: American Heart Association (Circulation)
- 2011 ACCF/AHA/SCAI Guideline for
Percutaneous Coronary Intervention (JACC)
- Protected PCI:
- 2014 AHA/ACC Guideline for the
Management of Patients With Non–ST-Elevation Acute Coronary
Syndromes (Circulation)
- 2011 ACCF/AHA/SCAI Guideline for
Percutaneous Coronary Intervention (JACC)
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. 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 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190220005532/en/
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 Apr 2024 to May 2024
ABIOMED (NASDAQ:ABMD)
Historical Stock Chart
From May 2023 to May 2024