ABMD heard about this on CBS radio this AM- I believe they said they are starting implants at UCLA medical center. At any rate I think it will be picked up on tonights news.
PRESS RELEASE: Abiomed Gets FDA OK To Begin Heart Studies
30 Jan 09:59
ABIOMED Gets O.K. From FDA to Begin Human
Implants of Artificial Heart
DANVERS, Mass.--(BW HealthWire)--Jan. 30, 2001--ABIOMED, Inc. (NASDAQ:ABMD),
a leader in heart assist and replacement technology, announced today that it
has received permission from the Food and Drug Administration (FDA) to begin
the initial clinical trial of its AbioCor(TM) Replacement Heart. The AbioCor,
the world's first implantable artificial heart, is intended as a destination
therapy for end-stage heart failure patients who are at risk of imminent death,
are not transplantable, and cannot be helped by other available therapies.
The Investigational Device Exemption (IDE) granted by the FDA allows for the
implantation of the AbioCor in the first five patients of the clinical trial.
Success of the trial will be based upon periodic review of the survival of
AbioCor patients and their quality of life as measured by a variety of
assessment instruments previously validated for end stage heart failure
patients. FDA's letter authorizing the trial requires ABIOMED to respond to a
number of questions within 45 days, but initiation of the trial is not
contingent upon those responses.
"This is a great day for everyone who has worked with so much dedication and
spirit to make the AbioCor a reality" said Dr. David M. Lederman, ABIOMED's
President and Chief Executive Officer. "Dozens and dozens of people have been
major contributors to ABIOMED's effort, under the leadership of Chief
Scientific Officer Dr. Robert T. V. Kung, Chief Regulatory Officer Janice T.
Piasecki, and AbioCor Program Director and Chief Engineering Officer William J.
Bolt. We will take a moment to celebrate, but only a moment. This FDA action
will further energize us as we make final preparations, at ABIOMED and at the
collaborating centers, for the initial human implants of the AbioCor."
"Our IDE submission for the AbioCor clinical trial was extraordinarily
comprehensive," Dr. Lederman continued, "totaling thousands of pages of highly
technical material in eighteen volumes. It is a testimony to the commitment and
professionalism of the FDA staff that they reviewed this material, submitted to
them just before the December holiday, so quickly, thoroughly and expertly. Our
interactions with members of FDA's Office of Device Evaluation over the past
several years have given us important direction in improving our testing
protocols and have thereby helped us to reach this landmark point in AbioCor's
development."
"We have benefited immensely from the enthusiastic support and the many
contributions of all of our collaborating centers and the members of our
Medical Replacement Heart Advisory Board. Special mention needs to be made of
Dr. O. H. (Bud) Frazier of the Texas Heart Institute, who has lent his clinical
insight to the AbioCor program for over a decade. The team at Jewish Hospital
in Louisville, Kentucky, led by Dr. Laman A. Gray and Dr. Robert D. Dowling,
has made major contributions over the past three years to the advancement of
our preclinical testing program and to our current state of preparedness." He
concluded: "We thank and acknowledge the vital support and encouragement from
the National Heart, Lung and Blood Institutes, who have sponsored the
development of AbioCor since 1988."
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. The Company's
AbioCor implantable replacement heart is in an advanced stage of development
and preparing for initial human trials. ABIOMED currently manufactures and
sells the BVS(R), a temporary heart assist device, for the support of all
patients with failing but potentially recoverable hearts.
The Company's AbioCor performance, timing and resultsmay differ materially
based on a number of factors, including uncertainty of successfully meeting
product development milestones, manufacturing milestones in light of complex
manufacturing processes, obtaining and maintaining regulatory approvals for
clinical trials, ability to train the clinical teams on a timely basis and to
obtain IRB approvals from the participating institutions, unproven markets for
products under development, dependence on key personnel, competition and
technological change, uncertainty in the ability to recruit required personnel
on a timely basis, government regulations, dependence on limited sources of
supply, dependence on third-party reimbursement, potential inadequacy of
product liability insurance, dependence on patents and proprietary rights and
other risks detailed in the Company's filings with the Securities and Exchange
Commission. Investors are cautioned that all such statements involve risks and
uncertainties. Readers are cautioned not to place undue reliance on these
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 after the date hereof or to reflect the occurrence of
unanticipated events.
CONTACT: ABIOMED, Inc.
Investor Contact:
John Thero, (978)777-5410
OR
Media Contact:
Edward E. Berger, Ph.D., (978)777-5410
KEYWORD: MASSACHUSETTS
INDUSTRY KEYWORD: MEDICAL DEVICES
Today's News On The Net - Business Wire's full file on the Internet
with Hyperlinks to your home page.
URL: businesswire.com
(END) DOW JONES NEWS 01-30-01
09:59 AM
Copyright 2001 Dow Jones & Company, Inc. |
