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Abiomed Announces Peripartum and Postpartum Cardiomyopathy Approval and Women’s Initiative for Heart Recovery | ||
By: Nasdaq / GlobeNewswire - 13 Feb 2018 | Back to overview list |
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DANVERS, Mass., Feb. 13, 2018 (GLOBE NEWSWIRE) -- Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support and recovery technologies, announced today the launch of a new indication and Women’s Initiative focused on heart recovery education and awareness. This Women’s Initiative is in conjunction with the Company’s expanded FDA approval for cardiogenic shock associated with cardiomyopathy, including peripartum and postpartum cardiomyopathy (PPCM). Clinical data collected in the cVAD Registry study included PPCM patients under the category of cardiomyopathy. According to the Centers for Disease Control and Prevention (CDC), cardiovascular disease is the number one killer of women and causes 35% of deaths (approximately 430,000) in American women over the age of 201. Two causes of death as a result of cardiogenic shock, specific to the female population are PPCM and spontaneous coronary artery dissection (SCAD).
Impella® heart pumps 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. Heart recovery is the ideal option for a patient's quality of life and as documented in several clinical papers, has the ability to save costs for the healthcare system8,9,10. Learn more about women who have recovered from PPCM and SCAD after hemodynamic support from Impella at www.heartrecovery.com.
“The Impella platform provides a new treatment option for women suffering from cardiogenic shock caused by cardiomyopathy,” said Cindy Grines, MD, Chair, Zucker School of Medicine at Hofstra/Northwell Health. “Additionally, unloading the heart so it can rest has the potential to improve outcomes specifically around heart recovery, for this young postpartum population. Education and patient awareness are also critical to properly diagnose and treat these patients.” “I am so grateful to be enjoying life without restrictions or limitations. Considering the nature of what happened, my story didn’t have to end that way, but it did,” said Lauri Evans, Impella patient. “And the more I learn, the more I understand what an important part Impella played.” “With our expanded indication, we can invest in education and awareness as we launch our Women’s Initiative for Heart Recovery. Abiomed will establish a new physician and patient advisory board to make heart recovery the standard of care for women suffering from cardiogenic shock,” said Michael R. Minogue, President, Chairman and Chief Executive Officer of Abiomed. “We are so motivated and inspired to be part of the team that allows these young and otherwise healthy new mothers, like Laura, Kristie and Lauri, to return home to their families with their native heart and live the lives they were meant to have.”
ABOUT IMPELLA HEART PUMPS The Impella 2.5®, Impella CP®, Impella 5.0® and Impella LD® are FDA-approved heart pumps used to treat heart attack or cardiomyopathy patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart. 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 FDA approved to treat patients experiencing acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. 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. ABOUT ABIOMED For further information please contact: 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 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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