Abiomed Announces First Patient Enrolled in STEMI DTU Feasibility Study
4.5.2017 13:01 | NASDAQ OMX
DANVERS, Mass., May 04, 2017 (GLOBE NEWSWIRE) -- Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support technologies, announced today the enrollment of the first patient in the Food and Drug Administration (FDA) approved prospective feasibility study, STEMI Door to Unloading (DTU) with Impella CP® system in acute myocardial infarction. This trial will focus on feasibility and safety of unloading the left ventricle using the Impella CP heart pump prior to primary percutaneous coronary intervention (PCI) in patients presenting with ST segment elevation myocardial infarction (STEMI) without cardiogenic shock with the hypothesis that this will potentially reduce infarct size.
The study, which received FDA approval in October 2016, is a prospective, multi-center feasibility study led by principal investigators Dr. Navin K. Kapur of Tufts Medical Center and Dr. William W. O'Neill of Henry Ford Medical Center. Up to 50 patients at 10 sites will be enrolled in the study, which is expected to be completed within 18 months.
The first patient in the study was enrolled in late April at Northwell Health System in Long Island, NY under the leadership of Dr. Perwaiz Meraj.
The primary endpoints of the feasibility study will focus on safety, including Adverse Cardiovascular and Cerebrovascular Events (MACCE) at 30 days. All patients will undergo cardiac magnetic resonance (CMR) imaging to assess infarct size as percent of left ventricular mass at 30 days post-PCI. Patients will be randomized to Impella CP placement with immediate primary PCI, or to Impella CP placement with 30 minutes of unloading prior to primary PCI. The hypothesis of this novel approach to treating STEMI patients, based on extensive mechanistic research, is that unloading the left ventricle prior to PCI reduces myocardial work load, oxygen demand and also initiates a cardio-protective effect at the myocardial cell level, which may alleviate myocardial damage caused by reperfusion injury at the time of revascularization. This feasibility study will help refine the protocol and lay the groundwork for a future pivotal study with more sites, patients and will be designed for statistical significance. Abiomed does not plan to announce additional enrollment status.
The ABIOMED logo, ABIOMED, Impella, Impella 2.5, Impella CP, Impella 5.0, Impella RP, and Recovering Hearts. Saving Lives. are registered trademarks of ABIOMED, Inc. in the U.S. and in certain foreign countries. cVAD Registry is a trademark of ABIOMED, Inc.
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.
For further information please contact:
Director, Investor Relations
Senior Director, Public Relations and Corporate Communications
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
Följ NASDAQ OMX
Skriv in din e-postadress så får du ett mejl när vi har något nytt att berätta.
Senaste nyheterna från NASDAQ OMX
Gaining Momentum: Vricon Hires Barry Tilton as CTO and VP of Engineering21.7.2017 15:21 | Pressmeddelande
McLean, Virginia, July 20, 2017 (GLOBE NEWSWIRE) -- Vricon, a global leader in 3D imagery, is pleased to announce the addition of Barry Tilton, who will join Vricon Systems LLC as the Vice President of Engineering and CTO for U.S. Government Programs. Vricon's mission is to build The Globe in 3D by producing photorealistic 3D products and digital elevation models with unmatched coverage and delivery timelines. Tilton will spearhead efforts to create new content and improve response times and product quality for Vricon's customers. Tilton brings a unique and extensive background in the Defense and Intelligence communities, having worked in remote sensing systems design and user support for a range of customers, to include the Air Force Space program, the National Geospatial-Intelligence Agency, the National Reconnaissance Office, the Office of the Director of Intelligence, and the Under Secretary of Defense for Intelligence. Tilton also has experience in international technic
REG Celebrates Completion of Upgrade Project at Emden Biorefinery20.7.2017 19:46 | Pressmeddelande
EMDEN, Germany, July 20, 2017 (GLOBE NEWSWIRE) -- Renewable Energy Group, Inc. (NASDAQ:REGI) marked the completion of upgrades at its Emden, Germany biorefinery Wednesday with a ribbon cutting ceremony with government and community members. REG invested 2.5 million € for the installation of a new biodiesel distillation column and a thermal oil heater. "This investment is another milestone in REG's European strategy to be a leader in delivering high quality biofuels," said Jean Scemama, Vice President, REG Energy Europe. "Within this strategy, Emden is positioned to perform well with deep water access to receive and deliver products by vessel and can now meet or exceed the highest quality standards required by our customers." "This project is a result of teamwork across REG's teams in Europe and the U.S." said Brad Albin, Vice President, Manufacturing. "Upgrading Emden's distillation capability enables us to more effe
Constellation Brands Elects Susan Somersille Johnson of SunTrust Banks, Inc. to its Board of Directors20.7.2017 15:38 | Pressmeddelande
VICTOR, N.Y., July 20, 2017 (GLOBE NEWSWIRE) -- Constellation Brands, Inc. (NYSE:STZ) (NYSE:STZ.B), a leading beverage alcohol company, announced today that its board of directors increased the size of the board from 10 to 11 members. In addition, the board elected Susan Somersille Johnson, corporate executive vice president and chief marketing officer of SunTrust Banks, Inc., to serve as a member of the board, effective as of the close of business on July 18, 2017. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/dfad4ec0-c876-49e9-9ff4-bc9f803b7cb1 "We're pleased to welcome Susan to the board of directors," said Constellation's Chairman of the Board Richard Sands. "Susan's deep understanding of brand strategy and marketing, as well as her passion for technology, will make a great addition to Constellation as we continue to build on the existing strengths of our board and the compan
Appian Extends its Capabilities with a New Robotic Digital Workforce Offering20.7.2017 15:00 | Pressmeddelande
Appian RPA with Blue Prism Brings Together Leading Business Process Management, Low-Code Application Development, and Robotic Process Automation (RPA) RESTON, Va., July 20, 2017 (GLOBE NEWSWIRE) -- Appian, (NASDAQ:APPN), a leading global provider of low-code application development and BPM software, today announced the addition of Blue Prism's industry leading Robotic Process Automation (RPA) capabilities to its platform. The new product offering, Appian RPA with Blue Prism, brings together leading low-code application development, BPM, and robotic workforce software for the first time as an offering from a single vendor. This offering builds on an already well-established partnership while giving organizations a one-stop-shop for all their enterprise automation needs, especially those that require the highest levels of auditing, security and scalability. "Appian's platform is now extended with robotic process automation from Blue Prism," said Matt
Jennifer Powers to join Global Infrastructure Partners as a Partner and Chair of GIP's Credit Business19.7.2017 18:16 | Pressmeddelande
For Immediate Release New York, July 19, 2017 (GLOBE NEWSWIRE) -- Global Infrastructure Partners (GIP), the leading, independent global infrastructure investment firm, announced today that Jennifer Powers will join GIP in September as a Partner and Chair of GIP's Credit Business. Ms. Powers will work closely with GIP Partner Jon Bram and GIP CAPS Fund Managing Partners Reiner Boehning and Steve Cheng to build out and expand GIP's Credit Business into a market leader in providing financing for infrastructure assets and projects. Ms. Powers joins GIP from Mizuho Bank where she was co-head of Investment Grade Debt Capital Markets. Prior to Mizuho, she was a founding member of the Royal Bank of Scotland's Credit Markets Business. Ms. Powers also spent 12 years in the energy investment banking and capital markets departments of Credit Suisse. Ms. Powers has extensive experience in advising and financing clients in the energy and infr
Solar Street Lights Illuminate Bujumbura, Burundi19.7.2017 16:10 | Pressmeddelande
Solar Pioneer Gigawatt Global Expands its Green Energy Offerings in Africa "By expanding our investments from commercial scale projects to include off-grid additionally, we are positively impacting the lives of millions of people in Burundi and throughout Africa" - Yosef I. Abramowitz, CEO, Gigawatt Global BUJUMBURA, Burundi, July 19, 2017 (GLOBE NEWSWIRE) -- Downtown Bujumbura just got a little brighter, thanks to an innovative partnership between Mayor Freddy MBONIMPA and Gigawatt Global (http://GigawattGlobal.com), a founding member of United States Power Africa's Beyond the Grid program. [Access multimedia content here: http://APO.af/ePScuQ/ http://APO.af/xxruhc/ http://APO.af/gdfypU/ http://APO.af/Xpw3uh ] This week solar-powered 'light islands' began appearing in the heavily-trafficked central bus station and
I vårt nyhetsrum kan du läsa de senaste nyheterna, få tillgång till pressmaterial och hitta kontaktinformation.Besök vårt nyhetsrum