Abiomed Launches Impella Quality (IQ) Assurance Program and Shares Insight From Largest Database of Real-World Evidence of High-Risk PCI and Cardiogenic Shock Patients
DANVERS, Mass., Oct. 31, 2016 (GLOBE NEWSWIRE) -- Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support and recovery technologies, announced today its Impella Quality (IQ) Assurance Program. The mission of the program is to improve real-world outcomes in Protected PCI and cardiogenic shock patients through training, education and utilization of clinical guidelines, protocols and best practices derived from observational quality assurance data (IQ), IRB approved registry data (cVAD) and IDE approved FDA studies.
These data resources include Abiomed's IQ Database, which is a collection of observational quality assurance data on over 95% of Impella patients since the Impella 2.5™ heart pump's introduction to the United States in 2008. Today, this holds more than 44,000 Impella case entries. This IQ database, combined with additional clinical data collected in the cVAD Registry™ and FDA pre- and post-market studies, has helped identify best practices and protocols that are linked to the highest survival and native heart recovery rates at the Impella hospitals. For example, the placement of Impella prior to doing a PCI in cardiogenic shock appears to improve outcomes.
We are sharing this with hospitals around the country as part of our comprehensive education and training initiatives with the goal of positively affecting both survival and recovery outcomes for this very high-risk patient population. Abiomed has invested more than $85 million in creating this collection of real-world evidence that is now being shared with our customers at no additional cost.
The goal of the IQ Program is to also complement these best practices with Abiomed's clinical field team, consisting of over 250 individuals in the United States. This experienced team, which includes physicians and nurses, has expertise in hemodynamic support and provides 24x7 onsite clinical assistance from the cath lab to the Intensive Care Unit (ICU). The company also provides 24x7 call center support staffed by experienced cardiac nurses and technologists. From an educational perspective, Abiomed has created case-based learning tools and reinforces guideline-based appropriate use treatment. The program also encourages the use of After Action Reviews, which is a continuous learning tool that hospital Heart Teams can implement to improve practices after each case. In addition, the appropriate use rationale includes seven society guidelines for the use of pVADs, supported by a compendium of resources on improved outcomes and cost effectiveness.
"Abiomed has created the largest high-risk PCI and cardiogenic shock database of real-world evidence with different levels of analysis from observational quality assessment, to IRB prospective registries, to FDA prospective randomized studies," said Michael R. Minogue, Abiomed President, Chairman and Chief Executive Officer. "We believe that by sharing our data-driven insights and clinical expertise, we can help hospitals create protocols, processes, and best practices to improve outcomes in Protected PCI and cardiogenic shock around native heart recovery."
The Impella products offer the unique ability to stabilize the patient's hemodynamics and unload the heart, which allows the muscle to rest and potentially recover its native function. Impella 2.5 received FDA PMA approval for high risk PCI in March 2015. Impella 2.5, Impella CP, and Impella 5.0 received FDA PMA approval for cardiogenic shock in the setting of acute myocardial infarction/heart attack or after heart surgery. These are the first and only percutaneous temporary ventricular support devices that are FDA-approved as safe and effective for the cardiogenic shock indication. The Impella product portfolio, which is comprised of Impella 2.5, Impella CP, Impella 5.0, Impella LD, and Impella RP, has supported over 40,000 patients in the United States.
The ABIOMED logo, ABIOMED, Impella, Impella CP, and Impella RP are registered trademarks of Abiomed, Inc. in the U.S.A. and certain foreign countries. Impella 2.5, Impella 5.0, Impella LD, and Protected PCI are trademarks of Abiomed, Inc.
Abiomed, Inc. based in Danvers, Massachusetts, 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.