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2016-12-07

Abiomed Impella CP Receives Expanded FDA Approval for High-Risk Percutaneous Coronary Intervention (PCI) Procedures

Abiomed Press release Abiomed Impella CP Receives Expanded FDA Approval for
High-Risk Percutaneous Coronary Intervention (PCI) Procedures Impella 2.5,
CP and 5.0 Only FDA Approved Percutaneous Heart Pumps Deemed Safe and
Effective DANVERS, Mass., 2016-12-07 13:00 CET (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™ 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. 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@abiomed.com Ingrid Goldberg Director,
Investor Relations 978-646-1590 igoldberg@abiomed.com

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