GlobeNewswire

Abiomed Announces European Approval (CE Marking) for Impella 5.5(TM) and First Patient Treated at University Heart Center Hamburg

Del

DANVERS, Mass., April 05, 2018 (GLOBE NEWSWIRE) -- Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart recovery and support technologies, announced today that the Impella 5.5(TM) heart pump received CE marking1 approval in Europe and the first patient was treated at University Heart Center in Hamburg, Germany. The Impella 5.5 heart pump further enhances Abiomed's product portfolio and provides physicians a 30-day, ambulatory, wean-able, forward flow heart pump.

Under the leadership of Professor Hermann Reichenspurner, MD, PhD, Alexander Bernhardt, MD treated the first patient, who presented with ischemic cardiomyopathy, severe mitral regurgitation and an ejection fraction of 18%. The patient currently remains stable on Impella 5.5 support.

The Impella 5.5 heart pump has the ability to provide peak flows of greater than 6.0 liters per minute. It is designed to be implanted in the axillary artery, avoiding the need for a sternotomy and allowing for patient ambulation. The Impella 5.5 is approved in Europe for up to 30 days of support and can be adjusted to nine power levels that regulate flow to optimize weaning protocols. The Impella 5.5 device includes the new SmartAssist technology with optical sensor, which will enable the integration of clinical data informatics including Left Ventricular Pressure (LVP), End-Diastolic Pressure (EDP) and Cardiac Power Output (CPO) on the Impella console as well as real-time, exact positioning of the Impella device. Over the next fiscal year, Abiomed plans to launch the Impella 5.5 heart pump through a controlled roll-out at German hospitals with established heart recovery protocols. Abiomed will continue to collect data on Impella 5.5 user experience and patient outcomes through our German hospitals submitting clinical data in the global cVAD Registry study.

Data Supporting CE Marking Approval

The data submitted for this CE marking approval included pre-clinical data on the Impella 5.5 and incorporates the clinical experience from over 3,000 patients, most all with axillary implants treated with the Impella 5.0 device. The submission also included an analysis of 68 patients from Abiomed's FDA reviewed cVAD Registry study treated with Impella 5.0® or Impella LD® heart pumps and a literature review of eight papers identifying patients treated with the Impella 5.0. Additionally, Abiomed submitted an analysis of 17 patients enrolled in the RECOVER I prospective, multicenter FDA IDE study.

"The Impella 5.5 device is an easy to implant, minimally-invasive device that provides full cardiac flow and stabilizes the patient by increasing cardiac power output, unloading the left ventricle and perfusing the coronaries and end organs," said Hermann Reichenspurner, MD, PhD, Professor and Chief, Department of Cardiovascular Surgery, University Heart Center Hamburg. "This approval gives our cardiovascular community a new option for effectively treating severely ill patients."

"We are excited about the Impella 5.5 and the impact of fully unloading the left ventricle," said Michael R. Minogue, President, Chairman and Chief Executive Officer of Abiomed. "We commend the dedication of the team at University Heart Center Hamburg. The addition of the Impella 5.5 to the Impella platform of devices will further address the clinical needs of patients and physicians as we advance the field of heart recovery."

  1. The CE marking approval for Impella 5.5 intended use is: 
    The Impella 5.5 heart pump is an intracardiac pump for supporting the left ventricle. It is intended for clinical use in cardiology and in cardiac surgery for up to 30 days for the following indications, as well as others: The Impella 5.5 is a cardiovascular support system for patients with reduced left ventricular function, e.g., post-cardiotomy, low output syndrome, cardiogenic shock after acute myocardial infarction; The Impella 5.5 may also be used as a cardiovascular support system during coronary bypass surgery on the beating heart, particularly in patients with limited preoperative ejection fraction with a high risk of postoperative low output syndrome.

ABOUT IMPELLA HEART PUMPS

The Impella 5.5 heart pump is not approved for use or sale in the United States.

The Impella 2.5®, Impella CP®, Impella CP® with SmartAssist, 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 
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.

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.

**For further information please contact: 
Ingrid Goldberg Ward
Director, Investor Relations
978-646-1590
igoldberg@abiomed.com




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Abiomed via Globenewswire

Om GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Følg saker fra GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra GlobeNewswire

Compuware Announces Day One Support for IBM CICS Transaction Server for z/OS V5.514.12.2018 18:02Pressemelding

DETROIT, Dec. 14, 2018 (GLOBE NEWSWIRE) -- Compuware Corporation, the world’s leading mainframe-dedicated software company, is pleased to announce Day One support for IBM CICS Transaction Server (TS) for z/OS V5.5. Compuware worked in collaboration with IBM to ensure that its solutions—including Abend-AID, File-AID, Strobe, Topaz and Xpediter—work seamlessly for z/OS customers installing or upgrading to this newest version of CICS TS. New capabilities within CICS TS V5.5 include support for JavaScript Node.js applications; an enhanced CICS Explorer; as well as advancements in systems management and enhanced security. “Compuware has an extensive history of ensuring our products work seamlessly with IBM releases and the release of CICS Transaction Server V5.5 is no exception,” said Sam Knutson, Vice President of Product Management for Compuware. “Our solutions excel at helping enterprises include the mainframe in their cross-platform Agile DevOps practices and processes so they can succe

SoftServe Achieves Machine Learning Specialization in Google Cloud Partner Program14.12.2018 13:00Pressemelding

Google Cloud recognizes SoftServe’s technical proficiency and proven success AUSTIN, Texas, Dec. 14, 2018 (GLOBE NEWSWIRE) -- SoftServe, a leading digital authority and consulting company, announces it achieved the Machine Learning Partner Specialization in the Google Cloud Premier Partner Program. The Partner Specialization affirms SoftServe’s expertise and success building customer solutions in the machine learning field using Google Cloud Platform (GCP) technology. The Google Cloud Partner Specialization Program is designed to provide Google Cloud customers with qualified partners that demonstrate technical proficiency in the specialized solution and service areas. Specifically, the Machine Learning Specialization demonstrates SoftServe’s expertise in data exploration, preprocessing, model training, model evaluation, model deployment, online prediction, and Google Cloud’s pre-trained machine learning APIs. “We teach machines to learn, read, see and understand business data, and make

Minerals Technologies Announces Price Increases for Specialty Minerals Products in Europe14.12.2018 00:01Pressemelding

NEW YORK, Dec. 13, 2018 (GLOBE NEWSWIRE) -- Specialty Minerals Inc. (“SMI”), a subsidiary of Minerals Technologies Inc., announced today that effective February 1, 2019, it will increase prices by up to 10% for all coated ultrafine precipitated calcium carbonate (PCC) from SMI’s Lifford Specialty PCC facility in Birmingham, UK, subject to individual customer contracts and market provisions. The price increases reflect increased market demand for higher performance materials, as well as significant inflation in input, raw material and logistics costs. About Minerals Technologies Inc. New York-based Minerals Technologies Inc. (MTI) is a resource- and technology-based growth company that develops, produces and markets worldwide a broad range of specialty mineral, mineral-based and synthetic mineral products and related systems and services. MTI serves the paper, foundry, steel, construction, environmental, energy, polymer and consumer products industries. The Company reported sales of $1.

Synthesio to Bring Proven Ipsos Data Science to Artificial Intelligence13.12.2018 17:03Pressemelding

Synthesio's Next-Generation Social Media Intelligence to Raise Unseen Insights to the Surface, Faster NEW YORK, Dec. 13, 2018 (GLOBE NEWSWIRE) -- Synthesio, an Ipsos company, and also the leading Social Media Intelligence Suite, today announced the plans for its next-generation Artificial Intelligence (AI) engine. The project will combine Synthesio’s AI technology with Ipsos’ data science. The combination will power upcoming Synthesio capabilities to help users find insights faster, remove guesswork, and make informed business decisions across a variety of use cases. “Our goal has always been to provide customers with meaningful data, visualized so that they can make strategic business decisions,” explained Loic Moisand, CEO & Founder of Synthesio. “The less guesswork that a company has to make, and the less time that it takes users to find meaningful insights, the more time for data-backed business decisions. We are really pleased that we can leverage the data science capabilities dev

XBiotech Announces Publication of Post-Hoc Analysis for Phase III Colorectal Cancer Study13.12.2018 14:00Pressemelding

Biomarkers Predict Significantly Higher Rates of Treatment Response to Bermekimab in Advanced Cancer Patients AUSTIN, Texas, Dec. 13, 2018 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) announced today the publication of findings on key biomarker analysis of colorectal cancer patients treated with bermekimab in its European Phase III study. The manuscript, entitled, “Interleukin-1 Receptor Antagonist (IL-1ra) Levels Predict Favorable Outcome after Bermekimab, a First-in-Class True Human Interleukin-1α Antibody, in a Phase III Randomized Study of Advanced Colorectal Cancer”, has been published online in the journal OncoImmunology. The findings report that patients with relatively low levels of IL-1ra or IL-6 were more likely to respond to bermekimab therapy and achieve the study’s primary endpoint. The study’s primary endpoint measured a combination of physical symptoms—pain, fatigue, anorexia and muscle wasting—which tend to worsen with advanced cancer, to assess whether these sympto

FROM CUTE TO CONFIDENT: MARY KAY INC. TALKS PINK AT THE MUSEUM AT FIT13.12.2018 14:00Pressemelding

Mary Kay Inc. and The Museum at The Fashion Institute of Technology Partner for a Pink-Centric Panel Discussion in Conjunction with Special Exhibition ‘Pink: The History of a Punk, Pretty, Powerful Color’ NEW YORK, N.Y., Dec. 13, 2018 (GLOBE NEWSWIRE) -- From pink makeup compacts to the iconic pink Cadillac, global beauty brand Mary Kay has been synonymous with the color pink for more than five decades. On December 13, 2018, Mary Kay will partner with The Museum at FIT (MFIT) to host a scholarly panel discussion, ‘Powerful Pink: From Cute to Confident,’ at the Katie Murphy Amphitheatre on the New York City FIT campus. Panelists include Luis Casco, Mary Kay Global Beauty Ambassador and celebrity makeup artist; Kate Greene, Vice President of Communications and Creative Direction at Givaudan and Karen Young, FIT adjunct professor and founder of The Young Group. The panel discussion will be moderated by Sheryl Adkins-Green, Chief Marketing Officer for Mary Kay Inc. The scholarly panel disc