| New
Cannula to Standardize and Enhance Ventricular Assist Device Implantations
DANVERS, Mass. (July 11, 2006)—Abiomed,
Inc. (NASDAQ: ABMD) today announced U.S. Food and Drug Administration
(FDA) approval of its Premarket Approval Application (PMA) supplement
for the Company’s new integrated cannula system. The new cannula
(previously referred to as “minimally invasive cannula”)
has the potential for use off-pump with minimally invasive procedures
and is designed to integrate with Abiomed’s AB5000™
and BVS® 5000 Circulatory Support Systems. The new cannula system
is easier to implant and explant and is expected to standardize
surgical procedures for acute heart failure patients.
Abiomed’s new cannula system provides an enhanced benefit
since patients will not require a second sternotomy during off-pump
explantations. Off-pump (also called beating heart) techniques provide
potential patient benefits of a shorter hospital stay and recovery
time, less bleeding, less potential for infection, and less trauma.
The new cannula system consists of a 42 French cannula, surgical
sewing cuff and an inline connector for precise implantation and
reduced blood loss for patients in acute heart failure.
“This new cannula system offers cardiovascular surgeons a
standardized and efficient circulatory support procedure for use
with patients in acute heart failure,” said Daniel Raess,
M.D., F.A.C.C., F.A.C.S., Medical Advisor at Abiomed. “The
device makes for easier off-pump implantations, minimizes damage
to the heart muscle and blood, and allows for easier explant of
circulatory support once the native function of the patient’s
heart has returned.”
“As we have developed our open-heart programs, and focused
on AMI patients, our users requested easier and quicker methods
to implant the cannula without requiring the support of a heart
lung machine, and the option to remove the cannula without requiring
a second sternotomy for patients who recover. As we simplify the
implantation and explantation process, we make our recovery VADs
more likely to be used as the standard of care for cardiogenic shock
at all surgery centers,” said Michael R. Minogue, Chairman,
CEO and President of Abiomed.
Abiomed’s ventricular assist devices (VADs) are the only
devices labeled for all potentially recoverable indications. To
date, more than 8,000 patients worldwide have been supported with
these devices. Patients who have recovered included those suffering
from cardiogenic shock resulting from myocardial infarction, myocarditis,
postpartum cardiomyopathy, ventricular septal defect, refractory
arrhythmias, failed heart transplants, right ventricular assistance
with implantable Left VAD (LVAD), and postcardiotomy cardiogenic
shock (PCCS). Abiomed’s devices encourage recovery and are
easier to implant, utilizing cannula inserted through a small incision,
rather than more traumatic bridge-to-transplant devices that core
the ventricles. The new cannula technology may be used with these
patients as they are provided circulatory support.
ABOUT ABIOMED’S NEW CANNULA
The new cannula system is a unique apical cannulation system designed
to simplify and minimize blood loss during implantation and explantation.
A key feature is a sliding seal that helps to control bleeding during
procedures.
During surgery, the surgical felt patch is trimmed to size and
sutured to the heart wall at the desired location. A special proprietary
tool makes an incision at the heart wall through the center of the
graft. Bleeding is controlled while the cannula is introduced into
the graft, across the incision site, and adjusted to the desired
depth. The base of the graft is secured to the cannula using umbilical
tapes or heavy gauge silk ties. During explantation, the tapes or
ties are removed, the cannula is withdrawn and the graft is sewn
over or stapled to seal the site.
- In addition to the new integrated off-pump cannula, Abiomed
offers a wide range of cannula options, including:
- 32 French Malleable, Ventricular Atrial
- 42 French Malleable, Ventricular Atrial
- 32 French Malleable, Short Apical
- 42 French Malleable, Short Apical
- 10mm Hemashield® Arterial Cannula
ABOUT ABIOMED
Based in Danvers, Massachusetts, ABIOMED, Inc. (pronounced “AB’-EE-O-MED”)
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™
Circulatory Support System and the BVS® 5000 Biventricular Support
System for the temporary support of all patients with failing but
potentially recoverable hearts. In Europe, ABIOMED offers the IMPELLA®
RECOVER® minimally invasive cardiovascular support systems under
CE Mark approval. The IMPELLA products are not yet available for
sale in the United States. The Company’s AbioCor® Implantable
Replacement Heart was the subject of an initial clinical trial under
an Investigational Device Exemption from the United States Food
and Drug Administration. The AbioCor has not been approved for commercial
distribution, and is not available for use or sale outside of the
initial clinical trial. For additional information please visit:
www.abiomed.com.
Contacts:
Liza Heapes
ABIOMED, INC.
Media Relations
(978) 646-1668
mediarelations@abiomed.com
Daniel Sutherby
ABIOMED, INC.
Chief Financial Officer
(978) 646-1812
ir@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.
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