Healthcare Industry News: left ventricular assist
News Release - March 17, 2008
Abiomed Receives Conditional FDA Approval for Impella 2.5 Study for Acute Myocardial Infarction (AMI) PatientsRandomized Study to Include 384 Patients At Up To 150 Sites
DANVERS, Mass.--(HSMN NewsFeed)--Abiomed, Inc. (NASDAQ: ABMD ) announced today that it has received conditional approval from the U.S. Food and Drug Administration (FDA) to begin its Impella®2.5 Circulatory Support System study in the United States under an investigational device exemption (IDE) for hemodynamically unstable patients undergoing a percutaneous coronary intervention (PCI) procedure due to acute myocardial infarction (AMI), commonly referred to as heart attack. This approval is conditional upon the Company's submission of additional information to the FDA over the next 45 days.
"This conditional approval for an AMI shock study represents an exciting opportunity to provide our breakthrough Impella heart recovery technology to a broader population of acute patients in the catheterization lab," stated Michael R. Minogue, Chairman, President and CEO of Abiomed. "We also continue to focus on our ongoing Impella 2.5 high-risk PCI pivotal trial and 510(k) clearance of our Impella 2.5 device.”
The AMI shock study will determine the safety and effectiveness of the Impella 2.5 as a left ventricular assist device for heart attack patients as compared to optimal medical management with an Intra-Aortic Balloon Pump (IABP). According to a recent American Heart Association report, approximately 865,000 AMI patients are treated annually in the U.S. The study is approved under category B2 status and the trial sites are eligible for full reimbursement from the Centers for Medicare and Medicaid Services (CMS).
The randomized study, at up to 150 hospitals, is comprised of two arms; those patients that receive the Impella 2.5 for up to five days as a left ventricular assist device (VAD) and patients that receive IABP therapy. The study will compare 192 Impella 2.5 patients to 192 IABP patients relative to a composite end point comparing safety and efficacy. The primary endpoint will be a composite endpoint of major events assessed at 30 days post-PCI. These major events include but are not limited to: death, acute renal failure, and need for a major cardiovascular operation. The secondary endpoint will be a composite of cardiac function such as ejection fraction, requirement for inotropic support and cardiac power output. Following Institutional Review Board (IRB) approval at each participating hospital and requisite training, the Company plans to ship Impella 2.5 disposables and Impella consoles to enrolled sites.
There are estimated over 100,000 AMI anterior infarct patients annually in the U.S. These patients suffer failure of the left ventricle, the large main pumping muscle of the heart. Feasibility studies show that of heart attack patients, these are the patients that can be most helped by the Impella 2.5 technology. For Abiomed, this translates to a potential market opportunity for the Impella 2.5 of more than $2 billion in yearly revenue for this indication alone.
In addition to this AMI study, Abiomed is currently conducting a high-risk PCI pivotal study for its Impella 2.5 device. There are an estimated 60,000 annual high-risk PCI patients in the U.S. representing a potential addressable U.S. market of over $1 billion. The Impella 2.5 is also under review by the FDA for 510(k) clearance which, if approved, would allow Abiomed to immediately begin selling the device to an estimated 14,000 interventional cardiologists at 1,900 hospitals in the United States.
The clinical experience to-date with Impella 2.5 has been favorable and the technology is now approved in more than 40 countries, including Europe under the CE Mark. Impella has been the subject of more than 40 peer reviewed publications. The Impella 2.5 device is a percutaneous device intended to provide the patients assistance of up to 2.5 liters of blood flow per minute. It is the world's smallest VAD and is already used outside the U.S. to treat conditions such as AMI, cardiogenic shock, and low output syndrome. The Impella 2.5 provides a new treatment option that aims to improve patient outcomes through a new standard of care.
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.
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 risk factors contained in the Company’s Annual Report filed on Form 10-K and recently filed 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.
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