Abiomed Impella CP Receives Expanded FDA Approval for High-Risk Percutaneous Coronary Intervention (PCI) Procedures
(Thomson Reuters ONE) -
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 system(1,2,3).
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 percent(4), increased patient quality of life by
58 percent(5), 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.
1. Maini B, Gregory D, Scotti DJ, Buyantseva L. Catheter Cardiovasc Interv.
2014 May 1;83(6):E183-92.
2. Cheung A, Danter M, Gregory D. J Am Coll Cardiol. 2012;60(17_S):.
doi:10.1016/j.jacc.2012.08.413.
3. 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.
4. Dangas GD, Kini AS, Sharma SK, et al. Am J Cardiol. 2014;113(2):222-228.
5. 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(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: 07.12.2016 - 13:00 Uhr
Sprache: Deutsch
News-ID 511479
Anzahl Zeichen: 11628
contact information:
Town:
Danvers
Kategorie:
Business News
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