Abiomed, Inc. (NASDAQ: ABMD) today announced the completion of the enrollment of 20 patients in its pilot clinical trial of the Impella® 2.5 Circulatory Support System. The trial will be completed after the Company has concluded all necessary post-enrollment patient monitoring.
The pilot study of the Impella 2.5 enrolled patients undergoing high-risk angioplasty procedures at the trial sites of William Beaumont Hospital, Brigham and Women’s Hospital, Massachusetts General Hospital, Texas Heart Institute, Cedars-Sinai Medical Center, Scripps Clinic and the Academic Medical Center in Amsterdam. Angioplasty, performed in the catheterization lab, is the insertion of a catheter-guided balloon and is used to open a narrowed coronary artery. A stent (a wire-mesh tube that expands to hold the artery open) is usually placed at the narrowed section. High-risk angioplasty is defined as patients undergoing angioplasty on an unprotected left main coronary artery lesion, or the last patent coronary conduit, and poor cardiac function.
“We are excited to reach this milestone for our Impella 2.5 technology, achieved through the dedicated efforts of the clinicians at our trial sites and the Abiomed team,” said Michael R. Minogue, Chairman, CEO and President of Abiomed.
In addition, Abiomed will host a conference call and Webcast at 1 p.m. ET on April 27, to discuss data on its Impella 2.5 presented by Dr. José P. Henriques from the Academic Medical Center in Amsterdam, at the American College of Cardiology’s (ACC) 56th Annual Scientific Sessions. The study, entitled “Preliminary Experience of the MACH 2 Trial: Safety and Feasibility of Left Ventricular Support with the Impella Recover LP2.5 Device in Patients with Acute ST-Segment Elevation Myocardial Infarction,” found that the Impella 2.5 improved cardiac function for pre-shock acute myocardial infarction (AMI or heart attack) as compared to conventional care including intra-aortic balloon pump (IABP) therapy.
The 20 patient MACH 2 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 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 at 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 at four months, respectively, in the Impella 2.5 group as compared to 2% and 5% in the control group.
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.
CONFERENCE CALL AND WEBCAST
The Company will host a conference call with Dr. José P. Henriques; Dr. William O’Neill, executive dean for clinical affairs at the University of Miami and the national principal investigator of the pilot study for the Impella 2.5; Dr. Karim Benali, chief medical officer at Abiomed; and Michael Minogue at 1 p.m. ET on Friday, April 27, 2007.
To listen to the call live, please tune into the Webcast via http://investor.abiomed.com or dial 800-798-2801; the international number is 617-614-6205. The access code is 18688274. A replay of this conference call will be available beginning at 3 p.m. ET on April 27, 2007 through May 4, 2007. The replay phone number is 888-286-8010; the international number is 617-801-6888. The replay access code is 95044880.
ABOUT ABIOMED
Based in Danvers, Massachusetts, Abiomed, Inc., is a leading provider of medical devices that provide circulatory support to acute heart failure patients across the continuum of care in heart recovery. Our products are designed to enable the heart to rest, heal and recover by improving blood flow and/or performing the pumping of the heart. For additional information please visit: www.abiomed.com.
FORWARD-LOOKING STATEMENTS
This Release contains forward-looking statements, including statements regarding progress toward completion of clinical trials for Abiomed’s products, including the Impella 2.5. 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 hospital and patient participation in trials, potentially conflicting results of future trials, the Company's ability to successfully obtain FDA approval of the Impella 2.5, development, testing and related regulatory approvals, complex manufacturing, high quality requirements, and other risks and challenges detailed in the Company's filings with the Securities and Exchange Commission, including its most recently filed quarterly report 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.
