Abiomed Impella 2.5 Receives FDA Approval for Elective and Urgent High Risk Percutaneous Coronary Intervention (PCI) Procedur...
March 23 2015 - 5:45PM
- Impella 2.5 is the Only FDA-Approved Percutaneous Hemodynamic
Support Device Determined to be Safe and Effective for the High
Risk PCI Indication
Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough
heart support technologies, today announced that it has received
U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA)
for the Impella® 2.5 heart pump during elective and urgent high
risk percutaneous coronary intervention (PCI) procedures. This
approval is based on the extensive clinical data submitted by
Abiomed to the FDA to support this PMA as part of the 515
initiative. Impella 2.5, the world's smallest heart pump, is the
first hemodynamic support device to receive a PMA indication for
use during high risk PCI procedures, demonstrating its safety and
effectiveness for this complex patient population.
With this approval, the Impella 2.5 is a temporary (≤ 6 hours)
ventricular support device indicated for use during high risk 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 in these patients may prevent hemodynamic
instability that may occur during planned temporary coronary
occlusions and may reduce peri- and post-procedural adverse
events.
The product labeling allows for the clinical decision to leave
Impella 2.5 in place beyond the intended duration of ≤6 hours due
to unforeseen circumstances.
Per the 2011 ACC/AHA guidelines, it is a Class 1 recommendation
for a heart team, which includes a cardiac surgeon, to determine
the treatment strategy for revascularization (either PCI or
surgery). This decision is made based on a pre-defined
institutional protocol or on a per patient basis. If the protocol
determines that PCI is appropriate, Impella is the only hemodynamic
support device proven safe and effective for high risk PCI. This
heart team approach has also been utilized for the treatment
strategy for heart valve replacement.
"The rigorous data from FDA clinical trials such as PROTECT I
and PROTECT II demonstrate that complex, high-risk patients
undergoing protected PCI with Impella 2.5 support experience
reduced adverse events, improved quality of life and are able to
return home faster with fewer repeat procedures," said William
O'Neill, M.D., Henry Ford Hospital in Detroit. "The heart team
approach has evolved into a mainstream practice recognized by the
guidelines for determining the need for PCI versus surgery and will
continue to act as a platform for the screening and determination
of the appropriate revascularization treatment for this high risk
patient population."
In addition to the U.S. clinical trial data, the Impella 2.5 PMA
submission included clinical and scientific supporting evidence
from more than 215 publications, totaling 1,638 Impella 2.5
patients and incorporated a medical device reporting (MDR) analysis
from 13,981 Impella 2.5 patients. In addition to PROTECT I and
PROTECT II, further data was provided in the submission from 637
high risk patients enrolled in the U.S. Impella registry. The
U.S. registry is an ongoing multicenter, observational
retrospective registry including 49 centers. The data collection
from the registry includes Institutional Review Board (IRB)
approval, complete data monitoring and Clinical Events Committee
adjudication. Additionally, the PMA analysis included hemodynamic
science described in the literature and validated with a series of
pre-clinical and clinical studies.
"Abiomed would like to thank the FDA and all the dedicated
caregivers and investigators for this achievement. The FDA approval
of the Impella 2.5 device is one of our most significant
milestones, representing a clinical advancement for physicians and
patients. The FDA's recognition of this elective and urgent patient
population is an important acknowledgement of their growing need
for treatment. As heart disease patients get sicker, more
complex, and desire minimally invasive solutions, there are few
options available to them to help improve their quality of life in
a cost effective manner," said Michael R. Minogue, Chairman,
President and Chief Executive Officer, Abiomed. "We are excited
that Impella has been recognized as a device that can potentially
become the new standard of care with a 'first of its kind'
approval."
ABOUT IMPELLA
The Impella 2.5 received 510(k) clearance from the FDA in 2008,
is supported by clinical guidelines, and has been reimbursed by the
Centers for Medicare & Medicaid Services (CMS) under ICD-9-CM
code 37.68 since 2008 for multiple indications, including high risk
PCI. The Impella product portfolio, which also includes the Impella
CP®, Impella RP™ and Impella 5.0, has supported over 25,000
patients in the United States. Per the regulatory process, Abiomed
will conduct a single arm, post approval study on the Impella 2.5,
collecting data on high risk PCI patients. The Impella CP and
Impella 5.0 will be submitted in the future as PMA supplements and
will retain their 510(k) clearances until completion of the FDA
process. The Impella RP device received Humanitarian Device
Exemption (HDE) approval in January 2015. For the Impella RP
Launch, the hospital heart team will be hosted at company
headquarters for a rigorous certification process followed by
on-site training at their hospital.
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. 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.
CONTACT: Aimee Genzler
Director, Corporate Communications
978-646-1553
agenzler@abiomed.com
Ingrid Goldberg
Director, Investor Relations
igoldberg@abiomed.com
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