DANVERS, Mass., May 09, 2017 (GLOBE NEWSWIRE) -- Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support and recovery technologies, announced the debut of the 3rd Generation Impella CP heart pump at the Annual meeting of the Society for Cardiovascular and Angiography Interventions (SCAI 2017) in New Orleans, LA. The technology offers new features for optimal care during a percutaneous coronary intervention (PCI) in high-risk patients known as a Protected PCI, and for patients being treated with Impella in the intensive care unit (ICU). The 3rd Generation Impella CP is a member of the Impella family of heart pumps which have the unique ability to unload the heart and enable native heart recovery, potentially allowing patients to return home with their own hearts. As the world’s smallest heart pump, the Impella platform has supported more than 50,000 patients in the U.S. alone, and is the only Food and Drug Administration (FDA)-approved percutaneous ventricular assist device (pVAD) indicated as safe and effective for PCI in high-risk patients1 and patients with Acute Myocardial Infarction complicated by Cardiogenic Shock (AMICS)2.
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Higher flows and ability to maintain access to arteriotomy
There are several new features on the Impella CP 3rd Generation that simplify patient management:
“The ability to introduce the Impella device simply and swiftly even in the presence of challenging femoral or iliac arteries will be valuable for interventional cardiologists caring for high-risk patients during PCI and for those in cardiogenic shock,” explained Seth Bilazarian M.D., FACC, FSCAI, Chief Medical Officer of Abiomed and experienced interventional cardiologist. He continued, “Enhanced flows will be very useful, as will the new guide wire repositioning unit which expands the options for access site closure or device exchanges.”
Fewer steps for the heart team
The ability to maintain access to the arteriotomy is particularly vital to the care of patients supported by the Impella device in the ICU long-term, such as those in cardiogenic shock. In addition, the Impella CP 3rd Generation heart pump offers fewer steps when flushing the system as part of standard maintenance.
"It’s intuitive and user-friendly,” said Christiana Gartner, RN, a Nurse Educator and experienced ICU nurse with extensive Impella experience at Greenville Health System who had the opportunity to test features of the 3rd Generation CP. She continued, “It's a time saver; you don’t question what's coming next. This software will make it easier to take care of your patient in the ICU."
Like all Impella heart pumps for the left side, the 3rd Generation CP® devices are designed for optimal positioning in the left ventricle and feature a flexible catheter, radiopaque marker, cannula shape and pigtail. The 3rd Generation Impella CP devices are now available in the U.S.
Real-world data suggest improvement in outcomes, but also significant underuse of Impella Technology
Since the Impella® platform received Pre-Market Approval (PMA) from the United States FDA for AMICS in April, 20162, Abiomed has continued tracking best practice data in the Impella Quality (IQ) Assurance Program, a real-world collection of clinical information derived from the treatment of patients with Impella devices since 2008. Results reveal that across sites using Impella devices to treat AMICS:
“These additions to the Impella CP represent the continuous innovation and commitment to patients that you’ve known since Impella was first introduced nine years ago,” said Abiomed President, Chairman and Chief Executive Officer Michael R. Minogue. “We continue to believe that data-driven insights and clinical expertise, along with our 24x7 onsite and on-call support, can help hospitals improve patient outcomes and reduce costs.”
Abiomed at SCAI 2017
The 3rd Generation Impella CP® heart pumps will be available for viewing at Booth # 404 beginning on May 10. During SCAI, we anticipate the opportunity to view three live cases that feature use of the Impella device.
As part of the conference agenda, experienced users of Impella devices will also lead discussions on critical industry challenges including:
ABOUT IMPELLA HEART PUMPS
The Impella 2.5®, Impella CP® and Impella 5.0® are FDA-approved heart pumps used to treat heart attack patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own hearts. The Impella 2.5 and Impella CP devices are also approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to re-open blocked coronary arteries. Abiomed's right-side heart pump, the Impella RP® device, is approved to treat certain patients experiencing right heart failure. To learn more about the Impella platform of heart pumps, including their approved indications and important safety and risk information associated with the use of the devices, please visit: www.protectedpci.com.
The ABIOMED logo, ABIOMED, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella CP, Impella RP, and Recovering Hearts. Saving Lives. are registered trademarks of ABIOMED, Inc. in the U.S. and in certain foreign countries.
Based in Danvers, Massachusetts, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest 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 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 the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, 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 most recently filed Annual Report on Form 10-K and 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.
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