Abiomed, Inc. (NASDAQ: ABMD), a leading provider of break-through heart support technologies, today announced the successful first human use of the Impella cVAD TM device, a new, percutaneous Impella heart pump that provides peak flow of approximately 4 liters of blood per minute. The Impella cVAD is designed to provide temporary circulatory support and reduce the workload of the heart muscle via a minimally invasive, catheter-based pump that is inserted percutaneously in the cardiac catheterization lab, without the need for surgical intervention. The Impella cVAD further enhances Abiomed’s product portfolio, providing cardiologists with the clinical flexibility to offer increased flow for patients requiring more hemodynamic support. The increased flow is delivered on the same console platform, 9 French catheter, and introducer as the Impella 2.5. An 85-year-old patient with complex coronary artery disease, compromised left heart function (ejection fraction of 20%), and prior myocardial infarction was percutaneously implanted with the Impella cVAD. The device generated an average blood flow of 3.5 liters and peak blood flow of approximately 4 liters per minute. Post procedure, the patient reported relief of angina; the Impella was explanted after 25 hours of support and the patient is currently awaiting discharge. For the first-in-man experience, the Impella cVAD was implanted at the McGill University Health Centre (MUHC) in Montreal, Quebec by Dr. Giuseppe Martucci, Co-Director of the Adult Intervention Congenital and Structural Health Disease Laboratory at the MUHC. Dr. Martucci was accompanied by Dr. Renzo Cecere, Dr. Luc Bilodeau, and Dr. Nicolo Piazza. “The Impella cVAD gave my patient a very high level of hemodynamic support, allowing me to conduct extensive revascularization and treat his triple-vessel coronary artery disease in one procedure — all while avoiding the accompanying risk of complications,” said Dr. Martucci. “This is another example of how the MUHC has made a safe, innovative, and minimally invasive procedure accessible to our patients. The device’s excellent blood flow gave us great flexibility and support and will allow the MUHC now to treat coronary artery disease patients who previously had limited treatment options and were unable to undergo traditional open-heart surgery,” added Dr. Cecere.
“We are extremely pleased to learn of the patient’s excellent results with the Impella cVAD and that the patient will not need to be re-staged for multiple PCI procedures,” said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. “The higher flow of the Impella cVAD can help offload approximately 80% of the heart’s work. The addition of the Impella cVAD to the growing Abiomed product portfolio further emphasizes the company’s goal to become the standard of care in every catheterization lab.”The MUHC heart team included Dr. Giuseppe Martucci, Co-Director of the Adult Intervention Congenital and Structural Health Disease Laboratory; Dr. Renzo Cecere, Director of the Mechanical Assist Program and Surgical Director of the Heart Failure and Heart Transplant Program; Dr. Luc Bilodeau, Director of the Cardiac Catheterization Laboratory; and Dr. Nicolo Piazza, Co-Director of the Adult Intervention Congenital and Structural Health Disease Laboratory. The Impella cVAD is not currently cleared for sale or use in the United States. 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 development of Abiomed's existing and new products, the Company's progress toward commercial growth, and future opportunities and expected regulatory approvals. 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, including 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 and 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.