Exhibit 99.1
Abiomed Announces FDA 510(k) Clearance for New Intra-Aortic Balloon
and Development of Integrated Console, the iPulse, for the Balloon,
BVS 5000 and AB5000
- Abiomed Enters $200M Balloon Pump Market with 160,000 Patients
Annually
- Broadens and Complements Abiomed Portfolio Across Spectrum of
Circulatory Support
DANVERS, Mass.--(BUSINESS WIRE)--Dec. 20, 2006--Abiomed, Inc.
(NASDAQ: ABMD) today announced U.S. Food and Drug Administration (FDA)
clearance of its new intra-aortic balloon (IAB); an easy-to-insert,
minimally invasive technology designed to enhance blood flow to the
heart and other organs for patients with diminished heart function.
The clearance by the FDA culminates more than two years of internal
research and development and reflects Abiomed's leading expertise and
core competency in advanced circulatory care technologies. This new
balloon was subject to extensive reliability testing and successfully
demonstrated a life of over eight million cycles, which equates to
more than 90 days of continuous operation. In addition to the IAB,
Abiomed has developed a combination console platform, the iPulse(TM),
currently under regulatory review and pending approval, to support the
new IAB. The new iPulse console will also support Abiomed's BVS and
AB5000 Circulatory Support Systems, as well as new product
introductions by Abiomed in the future. The iPulse is also designed to
be compatible with other OEM's balloons as well.
The IAB extends Abiomed's clinical and market reach further
upstream in acute patient care, including direct usage in the
intensive care unit (ICU). The IAB complements Abiomed's products in
the cardiac catheterization (cath) lab and surgical suite, allowing
access to more acute patients. There are an estimated 1.1 million
acute heart failure patients annually in the United States alone, with
such conditions as acute myocardial infarction (AMI or heart attack),
cardiogenic shock, myocarditis, postcardiotomy cardiogenic shock, or
patients needing support for high-risk cardiac procedures. Abiomed's 8
French IAB is inserted percutaneously into a patient's descending
aorta and inflates and deflates in counterpulsation to a patient's
heart rhythm.
The new iPulse console will now support procedures with associated
Medicare reimbursement that extends across four diagnostic related
groups (DRGs 110, 111, 525, 103) ranging from $15,000 to $180,000 per
patient stay. The return on capital investment for the iPulse console
can be achieved in less than six months.
"We believe this IAB offering and integrated iPulse console
provide an opportunity to accelerate our revenue growth as we launch
these products in the global markets. We also expect the technology to
fuel demand for our AB5000 consoles and ventricles as we leverage our
installed base in the surgical suite, where roughly one third of
intra-aortic balloons are inserted," said Michael R. Minogue,
Chairman, CEO and President of Abiomed. "Abiomed plans to enter this
$200 million additional market consisting of 160,000 patients with a
combination of our IAB, Impella and AB5000 technologies to achieve the
best recovery outcomes. Abiomed has the most extensive portfolio of
circulatory care technologies in the industry and a strong platform
for new product introductions."
"Intra-aortic balloons are the first line of therapy and one of
the most utilized technologies for circulatory support," stated
William O'Neill, M.D., Professor of Cardiology & Executive Dean for
Clinical Affairs, Miami University. "From its new intra-aortic balloon
to the Impella in the cath lab for high-risk angioplasty, Abiomed now
has a full line of prophylactic and therapeutic solutions to recover
or protect the failing heart."
"There is a definite need for a spectrum of care in circulatory
support for patients suffering hemodynamic instability. A clinical
strategy that provides support from IAB to Impella to AB5000 allows
physicians to tailor the therapy based on patient need," said Robert
L. Kormos, M.D., Co-Director Heart Transplantation, Director
Artificial Heart Program and Medical Director of the McGowan Institute
for Regenerative Medicine in Pittsburgh, PA.
"There is a need for both continuous flow and pulsatile flow to
maximize recovery outcomes. With the Impella and iPulse consoles,
Abiomed provides optimal support for acute patients whether they are
in pre-shock or profound shock," said Robert Dowling, M.D., Professor
of Surgery at the University of Louisville School of Medicine and
Jewish Hospital.
Abiomed expects to begin shipping its integrated iPulse console
outside the U.S. during fiscal fourth quarter ending March 31, 2007.
Following FDA approval of the pre-market application (PMA) supplement
to the existing console, Abiomed's initial introduction of the new
iPulse is expected in the summer of 2007 to leading heart hospitals.
This innovative IAB technology strengthens Abiomed's portfolio of
products, which now includes three platforms (Impella, iPulse, and
AbioCor) and consists globally of seven disposable devices that span
the cath lab to the intensive care unit to the surgery suite.
CONFERENCE CALL AND WEBCAST INFORMATION
A conference call and webcast to discuss Abiomed's new IAB is
scheduled for 9:00 AM Eastern, December 21, 2006. To participate in
this call within the U.S. and Canada, dial 888-396-2369; international
callers should dial 617-847-8710. The conference ID is 43758491. A
replay of the call will be available two hours after the call and will
be available for one week. To access the replay within the U.S. and
Canada, dial 888-286-8010; international callers should dial
617-801-6888. A webcast of the call, which will be live and then
archived, will also be available at www.abiomed.com.
ABOUT ABIOMED
Based in Danvers, Massachusetts, Abiomed, Inc., is a leading
developer, manufacturer and marketer of medical products designed to
assist or replace the pumping function of the failing heart. Abiomed
currently manufactures and sells the AB5000(TM) Circulatory Support
System and the BVS(R) 5000 Biventricular Support System for the
temporary support of all patients with failing but potentially
recoverable hearts. The Company also developed the AbioCor(R)
Implantable Replacement Heart. In Europe, Abiomed offers the minimally
invasive Impella(R) Circulatory Support System under CE Mark approval.
The Impella(R) 5.0 and 2.5 are investigational devices limited by
Federal Law solely to investigational use in the United States. Other
Impella devices are not yet available for sale in the United States.
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. 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, 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. 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: Abiomed, Inc.
Daniel J. Sutherby, 978-646-1812
Chief Financial Officer
ir@abiomed.com
or
Liza Heapes, 978-646-1668
Media Relations
mediarelations@abiomed.com