DANVERS, Mass., Oct. 24 /PRNewswire-FirstCall/ -- ABIOMED, Inc. , a leading developer, manufacturer and marketer of medical products designed to assist or replace the pumping function of the failing heart, announced data presented at the Cardiovascular Research Foundation's (CRF) 17th annual TCT scientific symposium in Washington, D.C., on its Impella Recover(R) LP 2.5, a minimally invasive percutaneous ventricular unloading catheter. The single center experience at the Academic Medical Center in Amsterdam of 21 patients has found that using the Impella as a left ventricular assist device during high-risk angioplasty/stenting procedures is both safe and feasible, providing hemodynamic support and improving coronary circulation, without compromising coronary blood flow. The results were described in two presentations.
The first presentation entitled, "Novel Hemodynamic Support During High- Risk Coronary Intervention," described the safety and feasibility of using the Impella Recover LP 2.5 as a left ventricular support in patients undergoing high-risk angioplasty/stenting procedures.
The second presentation entitled, "LV (Left Ventricular) Support Device Impella Increases Coronary Blood Flow in Patients with Compromised LV Undergoing Angioplasty," also by Dr. J.P.S. Henriques, Cardiologist at the Academic Medical Center in Amsterdam, additionally studied coronary blood flow in a total of 11 patients undergoing high-risk angioplasties. This study showed that the CE Marked Impella Recover LP 2.5 not only unloads the heart but that can also increase coronary perfusion needed to provide oxygen to the heart itself.
"In our experience using the Impella Recover LP 2.5, we found the device to be easy-to-use in the cath lab setting and capable of providing hemodynamic support and improved and sustained coronary circulation," said Dr. Henriques. "The Impella 2.5 enables us to perform increasingly more difficult procedures like stent placement and angioplasty in compromised patients with preserved and even improved coronary circulation. We were pleased with our findings and look forward to continuing to use and study this important new technology."
The Impella Recover LP (Left Percutaneous) 2.5 can deliver up to 2.5 liters of blood per minute and actively unloads the ventricle, increasing the cardiac output and both coronary and end-organ perfusion. It is minimally invasive and can be inserted into the left ventricle in a catheterization lab via a standard guidewire. The Impella Recover technology has been used in European centers to support more than 400 patients during high-risk percutaneous coronary intervention (PCI), post PCI, Acute Myocardial Infarction (AMI or heart attack) and patients with compromised hemodynamics. This device provides cardiologists with the first technology designed to support patients in the cath lab, during minimally invasive yet high-risk procedures, such as high-risk stent placement.
"Dr. Henriques' studies support the Impella Recover technology as an early, minimally invasive Ventricular Assist Device that can help protect and recover the patient's natural heart," said Michael R. Minogue, Chairman, CEO and President of ABIOMED. "ABIOMED will work towards approval of The Impella Recover LP 2.5 to allow interventional cardiologists to provide their patients with immediate support in the cath lab, without needing to send the patient to the surgery suite, and without requiring that they endure a sternotomy."
IMPELLA DEVICES
Impella products are investigational devices limited by Federal Law solely to investigational use in the United States and are not yet available for sale in the United States.
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(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. In Europe, ABIOMED offers the Impella(R) Recover(TM) minimally invasive cardiovascular support systems under CE Mark approval. The Company's AbioCor(R) 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: http://www.abiomed.com.
Contacts: Liza Heapes Investor Relations Contact: ABIOMED, INC. Melody Carey Media Specialist Rx Communications Group, LLC 978-646-1668 917-322-2571 mediarelations@abiomed.commcarey@rxir.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.
ABIOMED, Inc.CONTACT: Liza Heapes, Media Specialist of ABIOMED, INC., +1-978-646-1668,mediarelations@abiomed.com; or Investor Relations Contact: Melody Carey ofRx Communications Group, LLC, +1-917-322-2571, mcarey@rxir.com
Web site: http://www.abiomed.com//
