Impella 2.5, CP and 5.0 Only FDA Approved
Percutaneous Heart Pumps Deemed Safe and Effective
DANVERS, Mass., Dec. 07, 2016 (GLOBE NEWSWIRE)
-- 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(TM) 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 (less
than or equal to 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
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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