Abiomed, Inc. (NASDAQ: ABMD) today announced the release of data on its Impella 2.5 presented at the American College of Cardiology’s (ACC) 56th Annual Scientific Sessions. ACC is the premier cardiovascular medical meeting, bringing together approximately 30,000 cardiologists to share developments in cardiovascular medicine.
Drs. Krischan D. Sjauw, Maurice Remmelink, Jan Baan, Jr., René J. van der Schaaf, Marije M. Vis, Karel T. Koch, Jan G. Tijssen, Jan J. Piek, Robbert J. de Winter, and José P. Henriques presented “Preliminary Experience of the MACH 2 Trial: Safety and Feasibility of Left Ventricular Support With the Impella Recover LP 2.5 Device in Patients With Acute ST-Segment Elevation Myocardial Infarction.” This study found that the Impella 2.5 improved cardiac function for pre-shock acute myocardial infarction (AMI or heart attack) as compared to conventional routine care including intra-aortic balloon pump (IABP) therapy.
“We have already published on the safety of the Impella 2.5 technology. Today we provide the first human study that documents the benefit of the Impella 2.5 to improve the left ventricular function post acute myocardial infarction as evidenced by the left ventricular ejection fraction,” said Dr. J.P.S. Henriques, Cardiologist at the Academic Medical Center in Amsterdam.
The 20 patient study looked at patients who were admitted for an AMI with hemodynamic instability, had the necessary procedure to re-open the blocked artery, and then received the Impella 2.5 or standard routine care including intra-aortic balloon-pump for a few days. The preliminary results showed that patients supported by the Impella 2.5 technology had significantly improved cardiac function at three days and four months after the heart attack as compared to the control group. The preliminary results showed an increase in ejection fraction of 9% and 13% at three days and four months, respectively in the Impella 2.5 group as compared to 2% and 5% in the control group.
In addition, a study presented at ACC by Dr. Melchior Seyfarth, a professor of cardiology at Deutsches Herzzentrum, Technische Universitaet, Muenchen, Germany, compared the effectiveness of the Impella 2.5 and the Intra-Aortic Balloon Pump (IABP). Dr. Seyfarth and his colleagues randomly assigned 26 patients who were in shock following a heart attack to circulatory support with the IABP or the Impella 2.5. They found that after 20 minutes of support, the amount of blood being circulated by the heart was significantly better in the group with the Impella 2.5. Cardiac output increased by 1.1 L/min in patients supported by the Impella pump, as compared to 0.2 L/min with the IABP. Investigators also noted a trend toward better mean arterial pressures with the Impella pump, which produced an increase of nearly 9.8 mmHg, as compared to a decrease of 1.2 mmHg with the IABP. During and after hospitalization, they measured additional indicators of blood circulation and clinical status as well.
“The new Impella 2.5 more effectively supports the circulation, providing a bridge for the patient and the failing heart until the heart is able to recover,” said, Dr. Melchior Seyfarth, a professor of cardiology at Deutsches Herzzentrum, Technische Universitaet, Muenchen, Germany.
“These studies of the Impella 2.5 show the promise of the technology for providing heart attack patients with improved blood flow. The technology can have applications in a number of procedures to help patients recover and return to their normal lives,” added Michael R. Minogue, Chairman, CEO and President of Abiomed.
The Impella 2.5 is a ventricular assist catheter, which is inserted percutaneously in the catheterization laboratory (cath lab) via the femoral artery into the left ventricle. Up to 2.5 liters of blood per minute are delivered by the pump from the left ventricle into the ascending aorta, providing the heart with active support in critical situations. The Impella 2.5 can be inserted quickly and provides cardiovascular support for up to five days. The device is currently available in Europe under CE Mark approval and is currently in pilot studies in the United States under an Investigational Device Exemption (IDE).
Abiomed plans to hold a conference call with Dr. Henriques in the future to discuss his experience and clinical studies of the Impella 2.5.
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™ Circulatory Support System and the BVS® 5000 Biventricular Support System for the temporary support of all patients with failing but potentially recoverable hearts. The Company also developed the AbioCor® Implantable Replacement Heart. In Europe, Abiomed offers the Impella® 2.5, Impella® 5.0, Impella® LD, the Impella® RD and an Intra-Aortic Balloon under CE Mark approval. The Impella® 5.0 and 2.5 are investigational devices limited by Federal Law solely to investigational use in the United States. Other Impella devices and the iPulse™ combination console system 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 our most recent quarterly report filed on Form 10-Q. 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.
