Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough
heart support and recovery technologies, today announced it has
expanded its U.S. Food and Drug Administration (FDA) pre-market
approval (PMA) for Impella heart pump use in high-risk percutaneous
coronary interventions (PCI) to include the Impella CP® heart pump.
The Impella heart pumps provide the only minimally invasive
treatment option with the unique ability to stabilize the patient’s
hemodynamics and unload the left ventricle of the heart, which
allows the muscle to rest and recover its native function. Heart
recovery is the ideal option for a patient’s quality of life and
has the ability to save costs for the healthcare system1,2,3.
In 2016, Impella CP’s first FDA PMA approval was for up to four
days of use to treat patients suffering from cardiogenic shock and
is identical to Impella 2.5 (4 days) and Impella 5.0 (6 days)
indications:
The Impella 2.5, Impella CP, Impella 5.0 and Impella LD™
catheters, in conjunction with the Automated Impella Controller,
are temporary ventricular support devices intended for short-term
use (<4 days for the Impella 2.5 and Impella CP, and <6 days
for the Impella 5.0 and Impella LD) and indicated for the treatment
of ongoing cardiogenic shock that occurs immediately (<48 hours)
following acute myocardial infarction (AMI) or open heart surgery
as a result of isolated left ventricular failure that is not
responsive to optimal medical management and conventional treatment
measures, including volume loading and the use of pressors and
inotropes, with or without IABP an intra-aortic balloon pump. The
intent of the Impella system therapy is to reduce ventricular work
and to provide the circulatory support necessary to allow heart
recovery and early assessment of residual myocardial function.
Today, Abiomed announces the second Impella CP indication for
FDA approval for high-risk PCI, identical to Impella 2.5:
The Impella 2.5 and Impella CP are temporary (≤ 6 hours)
ventricular support systems indicated for use during high risk
percutaneous coronary interventions (PCI) performed in elective or
urgent hemodynamically stable patients with severe coronary artery
disease and depressed left ventricular ejection fraction, when a
heart team, including a cardiac surgeon, has determined high risk
PCI is the appropriate therapeutic option. Use of the Impella 2.5
and Impella CP in these patients may prevent hemodynamic
instability which can result from repeat episodes of reversible
myocardial ischemia that occur during planned temporary coronary
occlusions and may reduce peri- and post-procedural adverse
events.
In the U.S. alone, Abiomed estimates there is a large unmet need
of approximately 121,000 high-risk patients annually who are
chronically ill with advanced, inoperable heart disease such as
severe coronary artery disease. Consensus publications and clinical
guidelines from the American College of Cardiology and Society for
Cardiac Angiography and Interventions have documented Impella heart
pumps as the new standard of care in algorithms to treat High-Risk
PCI. Impella 2.5 and Impella CP heart pumps are the only
hemodynamic support devices proven safe and effective by the FDA
for high-risk PCI and AMI cardiogenic shock.
“This latest approval for Impella expands the hemodynamic
options for the cardiovascular community to effectively
revascularize severely ill patients who have limited options and
high mortality risk,” said Jeffrey W. Moses, MD,
Professor of Medicine, Columbia University Medical
Center. “Backed by clinical data and real world experience since
2008, interventional cardiologists working with their heart teams
to identify complex PCI candidates can perform complete
revascularization on previously untreatable patients to improve
their quality of life and their native heart function.”
Data submitted from an FDA IDE approved, randomized multicenter
trial (Protect II) demonstrated that Protected PCI with Impella
heart pumps reduced major adverse events (MACCE) by 29 percent4,
increased patient quality of life by 58 percent5, and showed
superior hemodynamics and improved cardiac power over the control
arm (IABP). Additionally, multiple independent analyses reveal
Impella usage is cost effective (ICER) or dominant (lowers absolute
costs) in emergency patients. Benefits from Impella-supported
procedures may also include a reduction in symptoms and class of
heart failure, reduction of days in the hospital, and a reduction
in readmissions due to fewer repeat procedures.
Data Supporting FDA
Approval
In addition to the robust data submitted for the Impella 2.5
approval, including the FDA safety study PROTECT I and the
Randomized Controlled Trial PROTECT II, the results from a
retrospective data review of 72 patients supported with Impella CP
and 637 patients treated with Impella 2.5 were submitted.
Post-market surveillance will be conducted through the cVAD
Registry. Additional clinical data submitted to the FDA by Abiomed
for approval consideration came from the cVAD Registry, previously
known as U.S. Impella registry, which contains nearly 3,000 patient
records. The data collection from the registry includes
Institutional Review Board (IRB) approval, complete data monitoring
and Clinical Events Committee adjudication.
In addition to data submitted to the FDA, the Abiomed Impella
Quality Assurance Program (IQ) includes a collection of
observational data on over 95 percent of Impella patients since the
heart pump's introduction to the United States in 2008. Today, this
holds more than 45,000 Impella case entries. These FDA studies, IRB
controlled registry, and Abiomed’s quality database are helping to
identify best practices and protocols that appear linked to the
highest survival and native heart recovery rates at the hospitals
with Impella.
“Abiomed would like to recognize the FDA and the principle
investigators in our FDA trials and cVAD registry for their
commitment to advancing research and treating the sickest heart
patients,” said Michael R. Minogue, President, Chairman and CEO of
Abiomed. “Abiomed is now able to partner with hospitals to expand
education and training and to focus on improving outcomes in both
high-risk PCI and AMI cardiogenic shock. As part of our customer
service, and without additional cost, we provide on-site 24/7
clinical support and an on-call center, as well as best practices
and protocols based on real world experience with over 45,000
patients.”
ABOUT IMPELLA
The Impella products offer the unique ability to stabilize the
patient's hemodynamics and unload the heart, which allows the
muscle to rest and potentially recover its native function. The
Impella 2.5 heart pump received FDA PMA approval for high risk PCI
in March 2015. The Impella 2.5, Impella CP, and Impella 5.0 heart
pumps received FDA PMA approval for the treatment of cardiogenic
shock following an acute myocardial infarction/heart attack or
after heart surgery. These are the first and only percutaneous
ventricular support devices that are FDA-approved as safe and
effective for the cardiogenic shock indication. The Impella product
portfolio, which is comprised of the Impella 2.5, Impella CP,
Impella 5.0, Impella LD, and Impella RP devices, has supported over
45,000 patients in the United States.
The ABIOMED logo, ABIOMED, Impella, Impella CP,
and Impella RP are registered trademarks of Abiomed, Inc. in the
U.S.A. and certain foreign countries. Impella 2.5, Impella
5.0, Impella LD are trademarks of Abiomed, Inc.
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.
- Maini B, Gregory D, Scotti DJ, Buyantseva L. Catheter
Cardiovasc Interv. 2014 May 1;83(6):E183-92.
- Cheung A, Danter M, Gregory D. J Am Coll Cardiol.
2012;60(17_S):. doi:10.1016/j.jacc.2012.08.413.
- Gregory D, Scotti DJ, de Lissovoy G, Palacios I, Dixon, Maini
B, O'Neill W. Am Health Drug Benefits. 2013 Mar;6(2):88-99.
- Dangas GD, Kini AS, Sharma SK, et al. Am J Cardiol.
2014;113(2):222-228.
- O’Neill WW, Kleiman NS, Moses J, et al. Circulation. 2012 Oct
2;126(14):1717-27.
For more 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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