Business/Health and Medical Writers
DANVERS, Mass.--(BW HealthWire)--Dec. 30, 1999
-- New Cannula Provides Additional Flexibility for BVS-5000(R) --
ABIOMED, Inc. (NASDAQ:ABMD) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Pre-Market Approval Application (PMA) Supplement for an additional arterial cannula, or cardiovascular connector, to be used with ABIOMED's BVS-5000 (the "BVS(R)") bi-ventricular assist device.
The BVS is a device that can temporarily take over the full pumping function of the heart. It is used to support patients with potentially reversible heart failure, allowing their failing hearts the opportunity to rest, heal and fully recover.
ABIOMED's new cannula is surgically attached to a heart's ascending aorta or pulmonary artery by a cardiac surgeon during the implantation of the BVS. This new cannula, partially comprised of a Hemashield(R) graft, is smaller in size than prior BVS cannulae and allows proper blood flow to be maintained.
"Cardiovascular surgeons continue to seek smaller cannulae that exhibit exceptional handling without compromising the flow characteristics," said Dr. David M. Lederman, President and Chief Executive Officer of ABIOMED. "This new cannula is an important addition to the Company's current product line. Furthermore, this new product demonstrates ABIOMED's ongoing commitment to research and development and furthers our mission of making the BVS the standard of care for cardiac recovery." Dr. Lederman added, "the introduction of this cannula also represents a first and major step forward in ABIOMED's strategic decision to develop and commercialize specialized thin-walled cannulae."
About the BVS-5000
The BVS, the most widely-used temporary heart assist device approved by the FDA through the PMA process, is now available in over 435 U.S. Medical Centers including over 80% of all major medical centers that perform more than 500 heart surgeries annually. The BVS is a temporary heart assist device that takes over the pumping function of a patient's failing natural heart allowing it the opportunity to rest, heal and fully recover. It is typically used in one of four patient indications: post-cardiotomy shock, viral myocarditis, failed transplant support or right-ventricular support with a Left Ventricle Assist Device (LVAD). The BVS is the only temporary cardiac assist device that is approved for the treatment of any patient with potentially reversible heart failure.
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. Based on technology that has been under development for nearly three decades, the Company's AbioCor(TM) Implantable Replacement Heart is in an advanced stage of development and undergoing testing in preparation for initial human trials. ABIOMED currently manufactures and sells the BVS, a temporary heart assist device, for the temporary support of all patients with failing but potentially recoverable hearts.
This News Release contains forward-looking statements, including statements regarding development and testing in preparation for initial human trials of the AbioCor(TM) Implantable Replacement Heart and the commercial introduction of a new BVS cannula. Actual results may differ materially based on a number of factors, including unproven markets for new technologies, uncertainties associated with AbioCor development, testing and related regulatory approvals, uncertainty regarding acceptance of new cannulae for the BVS, anticipated future losses, complex and high quality manufacturing requirements, dependence on limited sources of supply, competition, technological change, government regulation, future capital needs and uncertainty of additional funding, dependence on third-party reimbursement 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 that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
ABIOMED(R) and the ABIOMED logo are registered service marks of ABIOMED Inc., AbioCor(TM) , BVS(R) and BVS-5000(R) are registered trademarks of ABIOMED, Inc. Hemashield(R) is a registered trademark of Boston Scientific Corporation.