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Abiomed: Abiomed Receives FDA IDE Approval for Initiation of Door to Unloading (DTU) Prospective Feasibility Study

Study Evaluates the Safety and Feasibility of Unloading of the Left Ventricle
with Impella CP® in STEMI Patients, without Cardiogenic Shock

DANVERS, Mass., Oct. 27, 2016 (GLOBE NEWSWIRE) -- Abiomed, Inc. (NASDAQ:ABMD),
a leading provider of breakthrough heart support and recovery technologies,
announced today the U.S. Food and Drug Administration (FDA) approval of a
prospective feasibility study to evaluate the use of the Impella CP heart
pump for unloading of the left ventricle prior to primary percutaneous
coronary intervention (PCI) in patients presenting with ST segment elevation
myocardial infarction (STEMI), without cardiogenic shock. This trial will
focus on feasibility and safety, and lay the groundwork for a future trial,
designed to measure the impact that unloading may have on infarct size
related to reperfusion injury, an acceleration of myocardial damage at the
time of revascularization, in STEMI patients.

Impella® heart pumps are not currently approved for use in STEMI patients
without cardiogenic shock. The STEMI patient segment is contributing to the
growing heart failure population and represents a potential new patient
indication that may benefit from Impella pump unloading the left ventricle.

STEMI is a type of heart attack caused by a blockage in one of the main heart
arteries, preventing the flow of oxygen to the heart. It is estimated that
965,000 people a year have heart attacks1, of which approximately 200,000 are
classified as STEMI2. The current standard of care is called Door to Balloon
"DTB", for the angioplasty balloon. The recommended treatment in guidelines
for STEMI is revascularization (opening the blocked artery) to restore oxygen
supply to the heart muscle through primary PCI within 90 minutes or less from
the time of first medical contact. Despite current guidelines, 76% of
patients experiencing their first acute myocardial infarction (AMI), will
develop heart failure within five years3. Additionally, within five years of
a patient surviving their first heart attack, 36% of men and 47% of women
will die due to heart failure1. It is estimated that the number of heart
failure patients will grow to 8 million people by 2030 with enormous
associated costs4. Survival from heart attacks has been improved by the
successful DTB protocol; however, this treatment is speculated to be
contributing to the growing epidemic of heart failure.

The study, "Door to Unloading (DTU) with Impella CP System in Acute Myocardial
Infarction to Reduce Infarct Size," is a prospective, multi-center
feasibility study led by principal investigators Dr. Navin K. Kapur of Tufts
Medical Center and Dr. William W. O'Neill of Henry Ford Medical Center. Up
to 50 patients at 10 sites will be included in the study, which is expected
to initiate in the first half of calendar 2017 and be completed within 18

The primary endpoint of the study will assess infarct size as percent of left
ventricular mass at 30 days post-PCI using a cardiac magnetic resonance (CMR)
imaging technique. Patients will be randomized to Impella CP placement with
immediate primary PCI, or to Impella CP placement with 30 minutes of
unloading prior to primary PCI. This feasibility study is designed to
evaluate safety and the protocol and not sized to show significant
statistical difference.

"As clinicians and scientists, we appreciate the FDA's approval of this
feasibility study," said Dr. Navin Kapur, "And we are excited to further
investigate whether mechanically reducing the workload of the heart before
reopening a blocked coronary artery reduces myocardial damage and the
subsequent development of heart failure."

"The majority of patients with large myocardial infarction involving the front
wall of the heart develop congestive heart failure within five years," said
Dr. William W. O'Neill. "The process of reperfusion with primary PCI should
be investigated with new therapeutic strategies targeting myocardial
reperfusion injury, which may improve clinical outcomes for patients."

The study hypothesis, based on extensive mechanistic research, is that
unloading the left ventricle prior to PCI reduces myocardial work load,
oxygen demand and initiate a cardioprotective effect which attenuates
myocardial damage caused by reperfusion injury at the time of

"Abiomed is committed to investing in innovative research to improve patient
outcomes. We believe that reducing heart muscle injury is the key to
recovering hearts, avoiding heart failure, improving patient quality of life
and reducing health care costs," said Michael R. Minogue, Abiomed President,
Chairman and Chief Executive Officer.

The Impella CP is a percutaneous catheter-based blood pump that can be placed
across the aortic valve into the left ventricle using a single femoral or
axillary arterial access to support systemic circulation. The device pumps
blood from the left ventricle into the ascending aorta at an average flow
rate of 3.5 L/min.

1 "Heart Disease and Stroke Statistics 2016 Update: A Report from the
American Heart Association Statistics Committee and Stroke Statistics
Subcommittee." (Circulation . 2016; 133(4); 38-360).
2 "Recent Trends in the Incidence, Treatment, and Outcomes of Patients with
ST and Non-ST-Segment Acute Myocardial Infarction," (Am. J. Med. 2011;
124(1); 40-47).
3 "Declining In-Hospital Mortality and Increasing Heart Failure Incidence in
Elderly Patients With First Myocardial Infarction," (J. Am. Coll. Cardiol.
2009; 53(1); 13-20).
4 "AHA Policy Statement: Forecasting the Impact of Heart Failure in the
United States." (Circulation . 2013.)


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. Impella 2.5 received FDA PMA
approval for high risk PCI in March 2015. Impella 2.5, Impella CP, and
Impella 5.0 received FDA PMA approval for cardiogenic shock in the setting of
acute myocardial infarction/heart attack or after heart surgery. These are
the first and only percutaneous temporary ventricular support devices that
are FDA-approved as safe and effective for the cardiogenic shock indication.
The Impella product portfolio, which is comprised of Impella 2.5, Impella CP,
Impella 5.0, Impella LD, and Impella RP, has supported over 40,000 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, and Protected PCI are trademarks of
Abiomed, Inc.


Abiomed, Inc. based in Danvers, Massachusetts, 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:


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.

For further information please contact:

Ingrid Goldberg,
Director, Investor Relations


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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