--(BUSINESS WIRE)--Apr. 3, 2012--
. (NASDAQ: ABMD), a leading provider of break-through heart
support technologies, today announced the successful first human use of
the Impella cVADTM
device, a new, percutaneous Impella heart
pump that provides peak flow of approximately 4 liters of blood per
minute. The Impella cVAD is designed to provide temporary circulatory
support and reduce the workload of the heart muscle via a minimally
invasive, catheter-based pump that is inserted percutaneously in the
cardiac catheterization lab, without the need for surgical intervention.
The Impella cVAD further enhances Abiomed’s product portfolio, providing
cardiologists with the clinical flexibility to offer increased flow for
patients requiring more hemodynamic support. The increased flow is
delivered on the same console platform, 9 French catheter, and
introducer as the Impella 2.5.
An 85-year-old patient with complex coronary artery disease, compromised
left heart function (ejection fraction of 20%), and prior myocardial
infarction was percutaneously implanted with the Impella cVAD. The
device generated an average blood flow of 3.5 liters and peak blood flow
of approximately 4 liters per minute. Post procedure, the patient
reported relief of angina; the Impella was explanted after 25 hours of
support and the patient is currently awaiting discharge.
For the first-in-man experience, the Impella cVAD was implanted at the
McGill University Health Centre (MUHC) in Montreal, Quebec by Dr.
Giuseppe Martucci, Co-Director of the Adult Intervention Congenital and
Structural Health Disease Laboratory at the MUHC. Dr. Martucci was
accompanied by Dr. Renzo Cecere, Dr. Luc Bilodeau, and Dr. Nicolo Piazza.
“The Impella cVAD gave my patient a very high level of hemodynamic
support, allowing me to conduct extensive revascularization and treat
his triple-vessel coronary artery disease in one procedure — all while
avoiding the accompanying risk of complications,” said Dr. Martucci.
“This is another example of how the MUHC has made a safe, innovative,
and minimally invasive procedure accessible to our patients. The
device’s excellent blood flow gave us great flexibility and support and
will allow the MUHC now to treat coronary artery disease patients who
previously had limited treatment options and were unable to undergo
traditional open-heart surgery,” added Dr. Cecere.
“We are extremely pleased to learn of the patient’s excellent results
with the Impella cVAD and that the patient will not need to
be re-staged for multiple PCI procedures,” said Michael R. Minogue,
Chairman, President and Chief Executive Officer of Abiomed. “The higher
flow of the Impella cVAD can help offload approximately 80% of the
heart’s work. The addition of the Impella cVAD to the growing
Abiomed product portfolio further emphasizes the company’s goal to
become the standard of care in every catheterization lab.”
The MUHC heart team included Dr. Giuseppe Martucci, Co-Director of the
Adult Intervention Congenital and Structural Health Disease Laboratory;
Dr. Renzo Cecere, Director of the Mechanical Assist Program and Surgical
Director of the Heart Failure and Heart Transplant Program; Dr. Luc
Bilodeau, Director of the Cardiac Catheterization Laboratory; and Dr.
Nicolo Piazza, Co-Director of the Adult Intervention Congenital and
Structural Health Disease Laboratory.
The Impella cVAD is not currently cleared for sale or use in the United
Based in Danvers, Massachusetts, Abiomed, Inc., is a leading provider of
medical devices that provide circulatory support to acute heart failure
patients across the continuum of care in heart recovery. Our products
are designed to enable the heart to rest, heal and recover by improving
blood flow and/or performing the pumping of the heart. For additional
information please visit: www.abiomed.com.
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 anticipated future losses, complex manufacturing, high quality
requirements, dependence on limited sources of supply, competition,
technological change, government regulation, 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 Annual Report filed on Form 10-K and most
recently filed 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.
Source: Abiomed, Inc.
Susie Lisa, CFA, 978-646-1590
Investor Relations and Corporate Development
Corporate Communications Manager