Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough
heart support and recovery technologies, today announced that it
has received an expanded U.S. Food and Drug Administration (FDA)
Pre-Market Approval (PMA) for the Impella 2.5
® and
Impella CP
® heart pumps during elective and urgent
high risk percutaneous coronary intervention (PCI) procedures. This
expanded indication confirms Impella support as appropriate in
patients with severe coronary artery disease, complex anatomy and
extensive comorbidities, with or without depressed ejection
fraction (EF).
Impella’s initial approval for High Risk PCI was based on two
FDA studies (PROTECT I and PROTECT II), that treated the sickest
and most severe patients in the catheterization lab with the
majority being denied open heart surgery. This change broadens the
appropriate use of Impella support and eliminates the requirement
for depressed ejection fraction in the presence of severe coronary
artery disease or complex anatomy (e.g., left main, multi-vessel,
or requiring rotational atherectomy). With this expanded approval,
the FDA has further validated this “first of its kind” indication
for High Risk PCI and the benefit of percutaneous hemodynamic
support in treating severely complex patients with mild, moderate
and severely depressed ejection fraction. Clinical society
guidelines from the ACC/HFSA/SCAI/STS consensus publication support
the use of Impella in patients with reduced or normal left
ventricular function and severe coronary artery disease for
treatment of anticipated technically challenging or prolonged PCI
patients1,2.
The Impella 2.5 and Impella CP heart pumps are the only
percutaneous temporary ventricular support devices FDA-approved as
safe and effective for High Risk PCI, with the new indication
stated below:
The Impella 2.5 and Impella CP are indicated for providing
temporary (< 6 hours) ventricular support during elective or
urgent high risk percutaneous coronary interventions (PCI)
performed in hemodynamically stable patients with severe coronary
artery disease, 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 the 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.
Data Supporting Expanded FDA Approval
The data submitted to the FDA in support of this expanded PMA
indication included an analysis of 229 consecutive patients with
mild to moderately reduced ejection fraction from the cVAD Registry
study. In this cohort, the majority of patients were
turned down for open heart surgery (CABG) due to their surgical
risk factors and remaining minority refused surgery. On
average, these patients were older, more often female, had more
lesions treated, experienced more hypertension and presented with
higher ejection fraction than patients in the CVAD registry cohort
with ejection fraction less than 35% (n=464). This comparison
demonstrated that high risk PCI with Impella support was feasible,
safe and achieved favorable outcomes in patients with mild to
moderately reduced ejection fraction.
The data collection from the cVAD registry includes
Institutional Review Board (IRB) approval, complete data monitoring
and Clinical Events Committee adjudication. This clinical data
reinforces prior FDA studies demonstrating the safety and
effectiveness of Impella support in elective, urgent and emergent
patient populations.
“This expanded FDA approval with moderately reduced ejection
fraction validates our real-world experience using hemodynamic
support in patients turned down for surgery with severe coronary
artery disease,” said Ehtisham Mahmud, MD, FACC, FSCAI, Division
Chief, Cardiovascular Medicine and Director, Sulpizio
Cardiovascular Center, UC San Diego. “These patients who have often
been managed medically in the past may have a new option for
treatment.”
“Our patients are increasingly more complex, requiring higher
levels of operator skill and protocol driven use of hemodynamic
support in the cath lab,” said Tony DeMartini, MD, FACC,
Interventional Cardiologist, Edward-Elmhurst Health. “These
patients often experience improved quality of life and with
complete revascularization can have improved ejection fraction
following Protected PCI.”
"Abiomed would like to thank the physician community,
caregivers, employees and regulators involved in the FDA clinical
trials and cVAD post market approval studies," said Michael R.
Minogue, President, Chairman and CEO of Abiomed. “Abiomed takes
great satisfaction in knowing that our significant investment in
clinical research over the last 12 years has helped thousands of
patients, identified best practices and expanded our regulatory
indications in both high risk PCI and cardiogenic shock.”
- Society for Cardiovascular Angiography and Interventions
(SCAI), American College of Cardiology (ACC), Heart Failure Society
of America (HFSA), Society of Thoracic Surgeons (STS)
- Rihal, C. Naidu, S, et al. 2015 SCAI/ACC/HFSA/STS Clinical
Expert Consensus Statement on the Use of Percutaneous Mechanical
Circulatory Support Devices in Cardiovascular Care. J Am Coll
Cardiol. 2015 May 19;65(19):e7-e26. doi:
10.1016/j.jacc.2015.03.036. Epub 2015 Apr 7.
ABOUT IMPELLA HEART PUMPS
The Impella 2.5®, Impella CP®, 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. The Impella 2.5 and Impella CP
devices are also 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. Abiomed's right-side heart pump,
the Impella RP® device, is FDA approved to treat patients
experiencing acute right heart failure or decompensation following
left ventricular assist device implantation, myocardial
infarction, heart transplant, or open-heart surgery. 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, and Recovering Hearts. Saving
Lives. are registered trademarks of ABIOMED, Inc. in the U.S. and
in certain foreign countries.
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.
For further information please contact:
Ingrid Goldberg Ward Director, Investor Relations 978-646-1590
igoldberg@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.
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