Impella is the most studied heart pump; Subject of comprehensive
post-market surveillance, 550+ academic publications, and a landmark
randomized controlled trial
DANVERS, Mass.--(BUSINESS WIRE)--Feb. 20, 2019--
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:
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
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
STEMI-DTU pivotal randomized controlled trial, which will compare
unloading the left ventricle with Impella to the current standard of
The ongoing Dan-Ger Shock randomized control trial for cardiogenic
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:
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
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
2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary
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
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.
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
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/
Source: Abiomed, Inc.
Director, Communications and Public Relations
Ingrid Goldberg Ward
Director, Investor Relations